Cataract Surgery Technique and Ocular Clarity

August 3, 2022 updated by: Nic J. Reus, MD, PhD, Amphia Hospital

Ocular Clarity After Cataract Surgery With Two Different Phacoemulsification Systems

The goal of this study is to study the restoration of quality of vision, expressed as straylight, in the immediate period after cataract surgery with two different phacoemulsification technologies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Cataract is an opacification of the lens. With cataract surgery, the lens is surgically removed after which a clear artificial intraocular lens is implanted. For patients, it is important that they regain functional vision as quickly as possible after surgery as a limited vision may increase the risk of falling and increases the dependency on other people. Surgical removal of the lens is done with a phacoemulsification system. Differences between phacoemulsification systems are the used pump type, the way the needle oscillates, and the fluid dynamics of the system. It is unknown whether any of the available systems offer an advantage on the amount of corneal oedema that develops after surgery and, therefore, results in a more rapid restoration of functional vision.

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 (Anticipated)

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.
15

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Nic J. Reus, MD, PhD
  • Phone Number: +31765952239
  • Email: nreus@amphia.nl

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of cataract in both eyes,
  • Having consented to and is planned to undergo cataract surgery in both eyes,
  • Planned for implantation of a non-toric monofocal intraocular lens (IOL) in both eyes,
  • A targeted refractive error of emmetropia,
  • Corneal astigmatism of ≤1.5 D,
  • Age of at least 18 years,
  • Willing and able to participate in both preoperative and postoperative examinations, and
  • Agreeing to sign the informed consent form.

Exclusion Criteria:

  • Insufficient understanding of the Dutch language to comply with study procedures,
  • Any comorbidity (other than cataract) that may significantly affect visual function and/or increase straylight and/or prolong visual recovery after surgery, such as significant macular degeneration, significant glaucoma, significant diabetic eye disease, significant ocular surface disease, cornea dystrophy, corneal opacification, significant vitreous opacities (such as asteroid hyalosis and clinically significant floaters), and history of cerebral vascular accident,
  • Subjects with a history of ocular surgery (e.g., corneal refractive surgery),
  • Subjects with an increased risk of complicated cataract surgery:
  • Lens subluxation or (phaco)iridodonesis,
  • Cataract brunescens, cataract rubra, cataract nigrans, or posterior polar cataract, and
  • History of ocular trauma,
  • Unability to be (reliably) measured with the C-Quant straylight meter or Pentacam corneal topographer, and
  • A calculated IOL power in any eye that prohibits implantation of the same type of IOL in both eyes.

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: Centurion
Cataract surgery performed with the Centurion phacoemulsification system
Procedure: cataract surgery with Centurion phacoemulsification system
Cataract surgery performed with the Centurion phacoemulsification system
Experimental: Quatera 700
Cataract surgery performed with the Quatera 700 phacoemulsification system
Procedure: cataract surgery with Quatera 700 phacoemulsification system
Cataract surgery performed with the Quatera 700 phacoemulsification system

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
Straylight
Time Frame: preoperative
Amount of straylight measured with C-Quant, expressed as log(s)
preoperative
Straylight
Time Frame: 1-2 hours after surgery
Amount of straylight measured with C-Quant, expressed as log(s)
1-2 hours after surgery
Straylight
Time Frame: 1 day after surgery
Amount of straylight measured with C-Quant, expressed as log(s)
1 day after surgery
Straylight
Time Frame: 1 week after surgery
Amount of straylight measured with C-Quant, expressed as log(s)
1 week after surgery
Straylight
Time Frame: 1 month after surgery
Amount of straylight measured with C-Quant, expressed as log(s)
1 month after surgery

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
Corneal densitometry
Time Frame: preoperative
Corneal densitometry measured with Pentacam, expressed as percentage
preoperative
Corneal densitometry
Time Frame: 1-2 hours after surgery
Corneal densitometry measured with Pentacam, expressed as percentage
1-2 hours after surgery
Corneal densitometry
Time Frame: 1 day after surgery
Corneal densitometry measured with Pentacam, expressed as percentage
1 day after surgery
Corneal densitometry
Time Frame: 1 week after surgery
Corneal densitometry measured with Pentacam, expressed as percentage
1 week after surgery
Corneal densitometry
Time Frame: 1 month after surgery
Corneal densitometry measured with Pentacam, expressed as percentage
1 month after surgery
Amount of phaco energy used
Time Frame: Surgery day
Amount of phaco energy used, expressed as Cumulative Dissipated Energy (CDE, for Alcon Centurion) or as Equivalent Phaco Time (EPT, for Zeiss Quatera 700)
Surgery day
Amount of balanced salt solution used
Time Frame: Surgery day
Amount of balanced salt solution used, expressed in milliliters
Surgery day
Total surgery time
Time Frame: Surgery day
Total surgery time per eye
Surgery day
Uncorrected Distance Visual Acuity
Time Frame: preoperative
Uncorrected Distance Visual Acuity, expressed as logMAR
preoperative
Uncorrected Distance Visual Acuity
Time Frame: 1-2 hours after surgery
Uncorrected Distance Visual Acuity, expressed as logMAR
1-2 hours after surgery
Uncorrected Distance Visual Acuity
Time Frame: 1 day after surgery
Uncorrected Distance Visual Acuity, expressed as logMAR
1 day after surgery
Uncorrected Distance Visual Acuity
Time Frame: 1 week after surgery
Uncorrected Distance Visual Acuity, expressed as logMAR
1 week after surgery
Uncorrected Distance Visual Acuity
Time Frame: 1 month after surgery
Uncorrected Distance Visual Acuity, expressed as logMAR
1 month after surgery
Corrected Distance Visual Acuity
Time Frame: preoperative
Corrected Distance Visual Acuity, expressed as logMAR
preoperative
Corrected Distance Visual Acuity
Time Frame: 1 day after surgery
Corrected Distance Visual Acuity, expressed as logMAR
1 day after surgery
Corrected Distance Visual Acuity
Time Frame: 1 week after surgery
Corrected Distance Visual Acuity, expressed as logMAR
1 week after surgery
Corneal pachymetry
Time Frame: 1 month after surgery
Corneal thickness measured with Pentacam, expressed as um
1 month after surgery
Corneal pachymetry
Time Frame: preoperative
Corneal thickness measured with Pentacam, expressed as um
preoperative
Corneal pachymetry
Time Frame: 1-2 hours after surgery
Corneal thickness measured with Pentacam, expressed as um
1-2 hours after surgery
Corneal pachymetry
Time Frame: 1 day after surgery
Corneal thickness measured with Pentacam, expressed as um
1 day after surgery
Corneal pachymetry
Time Frame: 1 week after surgery
Corneal thickness measured with Pentacam, expressed as um
1 week after surgery
Presence of corneal oedema
Time Frame: preoperative
Presence of corneal oedema with slit lamp biomicroscopy
preoperative
Presence of corneal oedema
Time Frame: 1-2 hours after surgery
Presence of corneal oedema with slit lamp biomicroscopy
1-2 hours after surgery
Presence of corneal oedema
Time Frame: 1 day after surgery
Presence of corneal oedema with slit lamp biomicroscopy
1 day after surgery
Presence of corneal oedema
Time Frame: 1 week after surgery
Presence of corneal oedema with slit lamp biomicroscopy
1 week after surgery
Presence of corneal oedema
Time Frame: 1 month after surgery
Presence of corneal oedema with slit lamp biomicroscopy
1 month after surgery
Catquest-9SF
Time Frame: preoperative
Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
preoperative
Catquest-9SF
Time Frame: 1-2 hours after surgery
Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
1-2 hours after surgery
Catquest-9SF
Time Frame: 1 day after surgery
Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
1 day after surgery
Catquest-9SF
Time Frame: 1 week after surgery
Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
1 week after surgery
Catquest-9SF
Time Frame: 1 month after surgery
Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
1 month after surgery
Patient-Perceived Satisfactory Improvement in Vision
Time Frame: 1-2 hours after surgery
Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
1-2 hours after surgery
Patient-Perceived Satisfactory Improvement in Vision
Time Frame: 1 day after surgery
Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
1 day after surgery
Patient-Perceived Satisfactory Improvement in Vision
Time Frame: 1 week after surgery
Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
1 week after surgery
Patient-Perceived Satisfactory Improvement in Vision
Time Frame: 1 month after surgery
Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
1 month after surgery

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.
Amphia Hospital

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: Nic J. Reus, MD, PhD, Amphia Hospital

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 (Anticipated)

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 1, 2022

Primary Completion (Anticipated)

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.
September 1, 2023

Study Completion (Anticipated)

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.
September 1, 2023

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).
July 29, 2022

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.
August 3, 2022

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 5, 2022

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.
August 5, 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.
August 3, 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.
August 1, 2022

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.
  • 1900

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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