Comparison of Clinical Outcomes on Trifocal IOLs FineVision POD F GF and FineVision POD F in Asian Eyes (PHY1706)

July 26, 2023 updated by: Beaver-Visitec International, Inc.

Clinical Study to Compare Clinical Outcomes of IOLs FineVision POD F GF (Hydrophobic) and FineVision POD F (Hydrophilic) After Bilateral Implantation in Asian Eyes

Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs with different material (hydrophobic and hydrophilic) from the same manufacturer. Implantation of the IOLs is bilaterally.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision POD F (both lenses: (PhysIOL, Liège, Belgium).

The devices under investigation (FineVision POD F GF and POD F) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The main difference between the lenses is the material (hydrophobic and hydrophilic). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of 12 study visits (1 preoperative, 2 operative and 9 postoperative) over a period of 36 months. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the 3 months follow up visit and secondary endpoint data will be collected at the 3, 12, 24 and 36 months follow up visits. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Makati City, Philippines, 1200
        • Asian Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Cataractous eyes with no comorbidity
  • Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Signed informed consent

Exclusion Criteria:

  • Unrealistic expectation
  • Age of patient <45 years
  • Irregular astigmatism
  • Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°
  • Difficulty for cooperation (distance from their home, general health condition)
  • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
  • Any ocular comorbidity
  • History of ocular trauma or prior ocular surgery including refractive procedures
  • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
  • Age-related Macular Degeneration (AMD) suspicious eyes (determined by OCT)
  • Complicated surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IOL implantation experimental
hydrophobic, trifocal intraocular lens POD F GF
Device: IOL implantation experimental
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
Active Comparator: IOL implantation active comparator
hydrophilic, trifocal intraocular lens POD F
Device: IOL implantation active comparator
Implantation of trifocal IOL POD F consisting of hydrophilic material

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
Time Frame: 3 months postoperative
No statistically significant difference between the two study groups on monocular UDVA at 3 months follow up visit. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014
3 months postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Manifested refraction
Time Frame: Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)
Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Distance Visual Acuity (UDVA) - monocular
Time Frame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly.
1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Distance Visual Acuity (UDVA) - binocular
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly.
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Corrected Distance Visual Acuity (CDVA) - monocular
Time Frame: Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly.
Pre-OP, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Corrected Distance Visual Acuity (CDVA) - binocular
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done binocularly.
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - monocular
Time Frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly.
1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) - binocular
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly.
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - monocular
Time Frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly.
1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) - binocular
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly.
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular
Time Frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly.
1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Distance Corrected Near Visual Acuity at 35cm (DCNVA) - binocular
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly.
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Near Visual Acuity at 35cm (UNVA)
Time Frame: 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly.
1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Uncorrected Near Visual Acuity at 35cm (UNVA)
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly.
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Contrast Sensitivity
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Contrast Sensitivity under photopic and mesopic light conditions
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Aberrometry
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
AcuTarget diagnostic device
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Measurement of Ocular Scatter Index (OSI) score to evaluate and compare the scattering of the implanted lenses.
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Visual Functioning Questionnaire - 25 (VFQ-25)
Time Frame: 3 months postoperative, 12 months postoperative.
Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified Visual Functioning Questionnaire - 25 (VFQ-25) will be used. The maximum score for each questionaire is 100.
3 months postoperative, 12 months postoperative.
Defocus Curve
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -5.0 D to +1.5 D. This examination is performed monocularly and binocularly.
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Corneal Status
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

• Corneal Status
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Fundus
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

• Fundus
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Signs of inflammation
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

• Signs of inflammation
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Pupillary block
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

• Pupillary block
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Retinal detachment
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

• Retinal detachment
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - Status of anterior and posterior capsule
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

• Status of anterior and posterior capsule
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - IOL decentration
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

• IOL decentration
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - IOL tilt
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

• IOL tilt
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - IOL discoloration
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

• IOL discoloration
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Slitlamp examination - IOL opacity
Time Frame: 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp:

• IOL opacity
3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraocular pressure (IOP) measurement
Time Frame: Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
The IOP will be measured with non-contact tonometer as part of the routine follow up examinations
Pre-OP, 1 day postoperative, 1 week postoperative, 1 month postoperative, 3 months postoperative, 12 months postoperative, 24 months postoperative, 36 months postoperative.
Keratometry
Time Frame: Pre-OP
Keratometric measurements are performed to calculate the required IOL power
Pre-OP
Biometry
Time Frame: Pre-OP
Biometry measurements are performed to calculate the required IOL power
Pre-OP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beaver-Visitec International, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Edward Ang, MD, Asian Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHY 1706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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