Clinical Trial: Two Different Cataract Surgical Procedures to Prevent Posterior Capsule Opacification

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effectiveness of Two Different Surgical Procedures to Prevent Posterior Capsule Opacification in Age-related Cataract Patients

Brief Summary: In this study, the investigators introduce a new "capsule-reserved" cataract surgical procedure in which anterior lens capsule is reserved and attached onto posterior lens capsule in the purpose of preventing posterior capsule opacification (PCO). A prospective randomized controlled study is reported to compare the new "capsule-reserved" surgical procedure with conventional one on the effectiveness to prevent posterior capsule opacification in age-related cataract patients.

Detailed Summary: A prospective, randomized controlled study of 240 eligible patients will been enrolled. Two eyes of each patient were assigned randomly to two groups respectively: Group I; anterior lens capsule is conventionally not reserved after continuous curvilinear capsulorhexis, while in Group II, anterior lens capsule is innovatively reserved and attached onto posterior lens capsule. This novel adjusted surgical procedure, featured by using the reserved anterior lens capsule to protect the peri-capsule microenvironment and prevent PCO, is conceptual different from the traditional cataract surgical procedure. Clinical examinations including posterior capsule opacification grading score, central posterior capsule thickness, central posterior capsule density, best corrected visual acuity, contrast sensitivity were carried out preoperatively and at each postoperative visit.
Sponsor: Sun Yat-sen University

Current Primary Outcome: Change from Baseline in posterior capsule opacification grading score [ Time Frame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, ]

Posterior capsule opacification（PCO）was recorded by standardized slit lamp retroillumination images and analyzed using the EPCO2000 program. The severity of PCO was clinically graded from 0 (none) to 4 (severe)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from Baseline in central posterior capsule thickness [ Time Frame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1 ]
    Central posterior capsule thickness was recorded and calculated by Pentacam HR system
  • Change from Baseline in central posterior capsule density [ Time Frame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1 ]
    Central posterior capsule density was recorded and calculated by Pentacam HR system.


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: May 4, 2015
Date Started: May 2015
Date Completion: August 2016
Last Updated: April 29, 2016
Last Verified: April 2016