Two Different Cataract Surgical Procedures to Prevent Posterior Capsule Opacification

Not Applicable

• Conditions: Cataract; Posterior Capsule Opacification
• Interventions: Procedure: Anterior lens capsule was reserved

• Registration Number: NCT02445274
• Lead Sponsor: Sun Yat-sen University

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 Description

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-03
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Aged 50 years or above
2. Both eyes were diagnosed with age-related cataract
3. Both eyes were planed to undergo the "Phacoemulsification and IOL implantation" surgery with 1 month
4. Biocular BCVA improvement post surgery was feasible judged by the ophthalmologists.

Exclusion Criteria

1. Other ocular diseases
2. ACD<3CT
3. Combined cataract surgery (trabeculoplasty, keratoplasty)
4. Lens pseudoexfoliation syndrome combined with glaucoma or zonular abnormalities
5. Previous intraocular surgery or trauma (laser not included)
6. Uveitis
7. Recent ocular infection
8. Proliferative diabetic retinopathy
9. Diabetes mellitus
10. Congenital ocular abnormalities (aniridia, congenital cataract)
11. Atrophy of iris
12. Participants with previous clinical trials 30 days before surgery
13. Using prostanoid eye drops
14. Uncontrolled systematic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capsule-reserved surgical procedure	Anterior lens capsule was reserved	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in posterior capsule opacification grading score	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)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in central posterior capsule thickness	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	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.

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China