Study of Endothelial Cell Condition After Cataract Surgery Performed Using Capsulorhexis or ZEPTO (ZEPTO)

March 8, 2022 updated by: Centricity Vision, Inc.

A Prospective Randomized Controlled Masked Study of Endothelial Cell Condition After Cataract Surgery Performed Using Manual Capsulorhexis or the ZEPTO Precision Capsulotomy System

This study will use images of the subjects' corneal endothelium obtained using non-invasive specular microscopy to obtain corneal endothelial cell density, the coefficient of variation in endothelial cell size, and the percentage of hexagonal endothelial cells following routine cataract surgery performed using the standard method of manual capsulorhexis compared to cataract surgery performed using Zepto Precision Capsulotomy System.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

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

  • United States
    • Texas
      • Eagle Pass, Texas, United States, 78852
        • Recruiting
        • UltraVision
        • Contact:
        • Principal Investigator:
          • Tomy Starck, MD
      • Houston, Texas, United States, 77008
        • Recruiting
        • Houston Eye Associates
        • Contact:
        • Principal Investigator:
          • Kevin Jong, MD
      • Houston, Texas, United States, 77025
        • Recruiting
        • Houston Eye Associates
        • Contact:
        • Principal Investigator:
          • Mark Vital, MD
      • San Antonio, Texas, United States, 78256
        • Recruiting
        • UltraVision
        • Contact:
        • Principal Investigator:
          • Tomy Starck, MD

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

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with symptomatic age-related lens cataract desiring lens extraction and IOL implantation.

Description

Inclusion Criteria:

  • Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the treatment of symptomatic age-related lens cataract, and then electing to undergo the study,
  • Subjects must be willing and able to return for scheduled treatment and follow-up examinations at 1 and 3 months.

Exclusion Criteria:

  • Pre-existing corneal endothelium pathology
  • Presence of guttae
  • Narrow angle glaucoma or advanced glaucoma
  • Psuedoexfoliation
  • Zonular abnormalities
  • Corneal endothelial cell density less than 1800 cells/mm2
  • Uveitis
  • Anterior chamber depth less than 2.5mm or greater than 3.75mm
  • Cataract grade LOCS II > 3
  • Posterior polar cataract
  • Planned implantation of IOL > 25D
  • Prior ocular surgery in the study eye
  • History of medications with potential corneal endothelial cell toxicity
  • Any condition that in the surgeon's judgement should exclude the subject from study enrollment.
  • Current participation in another drug or device clinical study, or participation in such a clinical study within the prior six months and during the duration of the current study

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Capsulorhexis
Capsulotomies conducted by Capsulorhexis
Diagnostic test: Imaging
Images of the corneal endothelium will be obtained using specular microscopy at 1- and 3-months post cataract surgery.
ZEPTO Precision Capsulotomy Device
Capsulotomies conducted by ZEPTO Precision Capsulotomy Device
Diagnostic test: Imaging
Images of the corneal endothelium will be obtained using specular microscopy at 1- and 3-months post cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial Cell Density Loss
Time Frame: 3 months
Post Cataract Surgery
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial Cell Density Loss
Time Frame: 1 month
Post Cataract Surgery
1 month
Coefficient of Variation in Endothelial Cell Size
Time Frame: 1 and 3 months
Post Cataract Surgery
1 and 3 months
% of hexagonal cells
Time Frame: 1 and 3 months
Post Cataract Surgery
1 and 3 months

Collaborators and Investigators

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

Sponsor

Centricity Vision, Inc.

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)

August 23, 2021

Primary Completion (Anticipated)

March 30, 2022

Study Completion (Anticipated)

May 30, 2022

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Endothelial Cell Density Loss

Clinical Trials on Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe