NCT03701139

Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cataract
• Posterior Capsule Opacification

Interventions

Type	Name	Description
PROCEDURE	posterior capsulotomy	After phacoemulsification with intraocular lens implantation, primary posterior capsulotomy will be performed to remove the primary posterior capsule opacification after posterior capsule polishing. A limited anterior vitrectomy will be performed if the anterior hyaloid surface is broken.
PROCEDURE	laser capsulotomy	A routine phacoemulsification with intraocular lens implantation is performed. Then the Nd:YAG laser capsulotomy will be performed 1 month postoperative to remove the primary posterior capsule opacification.

Timeline

• Start date: 2018-10-10
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2018-10-09
• Last updated: 2018-10-17

Locations

1 site across 1 country: China