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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-23

Study Completion Date

2022-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Endothelial Cell Density Loss

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Capsulorhexis

Capsulotomies conducted by Capsulorhexis

Imaging

Intervention Type DIAGNOSTIC_TEST

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

Imaging

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Imaging

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes