An interventional study of Anterior lens capsule was reserved in Cataract and Posterior Capsule Opacification, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-05-03.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 240 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
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Exclusion Criteria:
In this group, the anterior lens capsule was reserved after continuous curvilinear capsulorhexis. The reserved anterior capsule was pressed flattened by the optical surface of the IOL and attached onto the posterior lens capsule. Phacoemulsification was performed with the same device and handpieces, using the same phaco chop technique as in the conventional procedure group.
Procedure: Anterior lens capsule was reserved
In this group, the anterior lens capsule was not reserved or attached onto the posterior lens capsule.
The anterior lens capsule was reserved after continuous curvilinear capsulorhexis. The reserved anterior capsule was pressed flattened by the optical surface of the IOL and attached onto the posterior lens capsule.
Change from Baseline in posterior capsule opacification grading score
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)
Time frame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3,
Change from Baseline in central posterior capsule thickness
Central posterior capsule thickness was recorded and calculated by Pentacam HR system
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
Change from Baseline in central posterior capsule density
Central posterior capsule density was recorded and calculated by Pentacam HR system.
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
Change from Baseline in best corrected visual acuity
Best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist.
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
Change from Baseline in contrast sensitivity
Contrast sensitivity under mesopic and photopic conditions was measured using C-quant
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
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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