Performance of Rigid Gas Permeable (RGP) Scleral Contact Lenses With a Passive Artificial Iris (RGPIRIS_PA)

April 19, 2022 updated by: University Ghent

Evaluation of Light Sensitivity and Visual Acuity Changes as Consequence of Rigid Gas Permeable (RGP) Scleral Contact Lenses With a Passive Artificial Iris

Data from 15 healthy subjects will be recorded in two testing sessions spread on two days, using three lens designs (A, B and C). Before the measuring days, each subject will undergo an extra fitting session of a large-diameter scleral contact lens on the dominant eye, assessed by an experienced practitioner. The fitting data will be used to custom-make the three lens designs for each subject, thus ensuring their comfort and safety during the days of the experiments. During the experiment days baseline measurements will be obtained before and after pupil dilation and contact lens wear. During the first testing session data from the lens design A (reference lens without artificial iris) will be recorded. During the second testing session data from the lens designs B and C (lenses with artificial iris with different transmittances) will be recorded. In each testing session, contrast sensitivity and visual acuity will be evaluated and non-invasive imaging measurements will be undertaken (optical coherence tomography and slit lamp). A specific questionnaire will be given to the subject to assess comfort, light sensitivity, the horizontal visual angle and overall experience of the scleral lens and in combination with a pair of sunglasses category 3-4.

Study Overview

Status

Status

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

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

First, the participant will be subjected to an RGP scleral contact lens fitting session, then during the second and third visits the participant will be subjected to several non-invasive procedures specific to the study in order to assess contrast sensitivity and visual acuity using the fitted and uniquely fabricated investigational medical devices. The tests will be performed after eye drops are supplied to dilate the pupil of the subjects (eye drops: tropicamide and phenylephrine). Besides the clinical experiments, the participant will be given a specific questionnaire in order to assess comfort, light sensitivity, horizontal visual angle and overall experience of the investigational medical device and in combination with a pair of sunglasses category 3-4. The investigators will document the occurrence of any adverse events and specific side effects during Day 2 and 3 (testing sessions with the investigational devices) in order to effectively assess their safety.

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.
10

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

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent (UZGent)

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

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Age between 18 and 45 years old

Exclusion Criteria:

  • Iris disorders (i.e. ocular albinism, coloboma, aniridia).
  • Known disease-related ocular surface problem (i.e. microbial keratitis).
  • Known ocular pathologies (except refractive disorders).
  • Coexistent ocular diseases impeding contact lens correction (i.e. glaucoma, previous ocular surgery).
  • Corneal scarring.
  • Low corneal endothelial cell count (< 1500 cells per mm2), with potential of corneal hypoxia-induced corneal edema induced by contact lens wear.
  • Wearing of contact lenses in the last 24 hours (prior to the interventions).

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: Healthy volunteers
15 healthy volunteers for trials with passive artificial iris
Device: Scleral contact lens without a passive artificial iris
Participants wear a scleral contact lens without a passive artificial iris (Design A) on the dominant eye to perform the baseline visual performance assessment
Other Names:
  • Control lens Design A
Device: Scleral contact lens with a passive artificial iris with low contrast (<1:5)
Participants wear a scleral contact lens with a low contrast (<1:5) passive artificial iris (Design B) on the dominant eye to perform the baseline visual performance assessment
Other Names:
  • Test lens Design B
Device: Scleral contact lens with a passive artificial iris with high contrast (>1:5)
Participants wear a scleral contact lens with a low contrast (<1:5) passive artificial iris (Design B) on the dominant eye to perform the baseline visual performance assessment
Drug: Tropicamide and phenylephrine
Participants receive pupil dilation eye drops on the dominant eye, after baseline measurement and before wearing the scleral contact lenses (Designs A, B and C)
Other Names:
  • Pupil dilation eye drops

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
Visual acuity assessment and comparison between Designs A, B and C by means of logMAR or equivalent value
Time Frame: 5 months from fitting session
Compare visual acuity values obtained with different designs
5 months from fitting session
Contrast sensitivity assessment and comparison between Designs A, B and C by means of threshold percentage or equivalent value
Time Frame: 5 months from fitting session
Compare contrast sensitivity values obtained with different designs
5 months from fitting session

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
Device safety by comparing eventual adverse events with those found in scleral contact lenses
Time Frame: 5 months from fitting session
Comparing adverse event of similar devices
5 months from fitting session
Correct fitting
Time Frame: 5 months from fitting session
Taking and analyzing ocular coherence tomography (OCT) images and slit lamp observations to estimate the clearance
5 months from fitting session
Contact lens wear comfort, as assessed by subject data from questionnaires Rasch analyzed using a 4-Andrich ration scale model
Time Frame: 5 months from fitting session
The subjective assessment will be carried out by means of questions on 3 content areas: lens comfort (3 questions), visual quality (4 questions) and general satisfaction with the lenses (3 questions).
5 months from fitting session
Visual acuity assessment and comparison between Designs B (low contrast) and C (high contrast) by means of logMAR or equivalent value
Time Frame: 5 months from fitting session
Comparing visual acuity between Designs B and C
5 months from fitting session
Contrast sensitivity assessment and comparison between Designs B (low contrast) and C (high contrast) by means of threshold percentage or equivalent value
Time Frame: 5 months from fitting session
Comparing contrast sensitivity between Designs B and C
5 months from fitting session
Horizontal visual angle
Time Frame: 5 months from fitting session
Angle at which the volunteer can see his fingers move when extending the arm (same side as dominant eye), 0°=arm extended to the side; 90°=arm straight ahead
5 months from fitting session

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.
University Ghent

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.
  • Study Chair: Andres F Vasquez Quintero, Professor, University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
September 16, 2019

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.
June 22, 2021

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.
June 22, 2021

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).
June 13, 2019

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.
July 30, 2019

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.
August 1, 2019

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.
April 27, 2022

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.
April 19, 2022

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.
November 1, 2021

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.
  • RGPIRIS_PA

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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