Status:

UNKNOWN

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

Lead Sponsor:

Centricity Vision, Inc.

Conditions:

Endothelial Cell Density Loss

Eligibility:

All Genders

50+ years

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 23 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 30 2022

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT04882189

Start Date

August 23 2021

End Date

May 30 2022

Last Update

March 22 2022

Active Locations (4)

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Page 1 of 1 (4 locations)

1

UltraVision

Eagle Pass, Texas, United States, 78852

2

Houston Eye Associates

Houston, Texas, United States, 77008

3

Houston Eye Associates

Houston, Texas, United States, 77025

4

UltraVision

San Antonio, Texas, United States, 78256