Recruiting

Capsulorhexis & ZEPTO

Sponsor:

Centricity Vision, Inc.

Code:

NCT04882189

Conditions

Endothelial Cell Density Loss

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Imaging

Study Details

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

Study ID

NCT04882189

Start date

Aug 23, 2021

Status verified date

Mar, 2022

Completion date

May 30, 2022

Anticipated

Primary completion date

Mar 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Capsulorhexis

Capsulotomies conducted by Capsulorhexis

ZEPTO Precision Capsulotomy Device

Capsulotomies conducted by ZEPTO Precision Capsulotomy Device

Interventions

Imaging

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

Primary outcome measure

  • Endothelial Cell Density Loss [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

UltraVision

Recruiting

Eagle Pass, Texas, United States, 78852

Contacts

Cinderalla Servin

210-308-5550cinderella@lasik2c.com

Principal Investigator:

Tomy Starck, MD

Houston Eye Associates

Recruiting

Houston, Texas, United States, 77008

Contacts

Bhavna Shah

832-553-7113bshah@houstoneye.com

Principal Investigator:

Kevin Jong, MD

Houston Eye Associates

Recruiting

Houston, Texas, United States, 77025

Contacts

Marcel Belloso

713-668-6828mailto:mbelloso@houstoneye.com

Principal Investigator:

Mark Vital, MD

UltraVision

Recruiting

San Antonio, Texas, United States, 78256

Contacts

Cinderalla Servin

210-308-5550cinderella@lasik2c.com

Principal Investigator:

Tomy Starck, MD

More Information

Sponsor

Centricity Vision, Inc.

Last update posted

Mar 22, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Centricity Vision, Inc. on 2022-03-22.