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

Status unconfirmed

Conditions studied: Endothelial Cell Density Loss

In brief

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.

Key facts

Study ID

NCT04882189

Run by

Centricity Vision, Inc.

People needed

80

Starts

2021-08-23

Expected to finish

2022-05-30

Last updated by the study team

2022-03-22

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• UltraVision — Eagle Pass, Texas, United States (enrolling)
• Houston Eye Associates — Houston, Texas, United States (enrolling)
• Houston Eye Associates — Houston, Texas, United States (enrolling)
• UltraVision — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.