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

NCT04882189 | Unknown DMC FDA Device

• 1 other identifier: 13803
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Endothelial Cell Density Loss

Outcome Measures

Primary Outcomes (1)

• Endothelial Cell Density Loss

  Post Cataract Surgery

  3 months

Secondary Outcomes (3)

• Endothelial Cell Density Loss

  1 month

• Coefficient of Variation in Endothelial Cell Size

  1 and 3 months

• % of hexagonal cells

  1 and 3 months

Study Arms (2)

Capsulorhexis

Capsulotomies conducted by Capsulorhexis

Diagnostic Test: Imaging

ZEPTO Precision Capsulotomy Device

Capsulotomies conducted by ZEPTO Precision Capsulotomy Device

Diagnostic Test: Imaging

Interventions

Imaging DIAGNOSTIC_TEST

Images of the corneal endothelium will be obtained using specular microscopy at 1- and 3-months post cataract surgery.

Capsulorhexis; ZEPTO Precision Capsulotomy Device

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centricity Vision, Inc.: lead

Study Sites (4)

UltraVision

Eagle Pass, Texas, 78852, United States

RECRUITING

Houston Eye Associates

Houston, Texas, 77008, United States

RECRUITING

Houston Eye Associates

Houston, Texas, 77025, United States

RECRUITING

UltraVision

San Antonio, Texas, 78256, United States

RECRUITING

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 11, 2021
• Study Start: August 23, 2021
• Primary Completion: March 30, 2022
• Study Completion: May 30, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

US (4)