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Clinical Trials/NCT03701139
NCT03701139
Unknown
Not Applicable

Phacoemulsification Combined With Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification: a Randomized Controlled Trial

Zhongshan Ophthalmic Center, Sun Yat-sen University1 site in 1 country40 target enrollmentOctober 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Enrollment
40
Locations
1
Primary Endpoint
LogMAR visual acuity 1 month postoperatively
Last Updated
7 years ago

Overview

Brief Summary

This is a two-arm, parallel group, open-label, randomized controlled trial to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular opacification (PPCO).

Detailed Description

Primary posterior capsular opacification (PPCO) refers to the posterior capsule opacification which cannot be removed by polishing or vacuuming during cataract surgery. The surgeon may have to decide on primary posterior capsulorhexis or early neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy in these cases. The aim of this study is to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular opacification (PPCO).

Registry
clinicaltrials.gov
Start Date
October 10, 2018
End Date
February 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yizhi Liu

Clinical Professor,director of Zhongshan Ophthalmic Center

Zhongshan Ophthalmic Center, Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • Cataract patients with primary posterior capsular opacification, which involves the central posterior capsular and interferes with visual axis;
  • Aged 18 years or over;
  • With best corrected visual acuity (BCVA) less than 0.3.

Exclusion Criteria

  • History of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.
  • Cases with operative complications, including anterior or posterior capsular rupture, lens suspensory ligament rupture, the falling of lens nucleus into vitreous cavity.
  • Unwillingness to participate in the study.

Outcomes

Primary Outcomes

LogMAR visual acuity 1 month postoperatively

Time Frame: 1 month

Best corrected visual acuity (LogMAR) will be measured 1 month postoperatively.

Secondary Outcomes

  • Modulation transfer function cut off (MTF cut off)(3 months)
  • Rate of intraocular lens damage(3 months)
  • Object scatter index (OSI)(3 months)
  • Predicted visual acuity (PVA) with contrasts of 100%, 20% and 10%(3 months)
  • Rate of retinal detachment(3 months)
  • Rate of ocular hypertension(3 months)
  • Rate of ocular macular edema(3 months)
  • Dysfunctional lens index (DLI)(3 months)
  • Internal higher order aberration (HOAs)(3 months)
  • Strehl ratio (SR)(3 months)
  • Visual-functioning index 7 score(3 months)

Study Sites (1)

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