Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification.

Sun Yat-sen University

Status: Unknown

Conditions: Cataract; Posterior Capsule Opacification

Treatments: Procedure: laser capsulotomy; Procedure: posterior capsulotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03701139

2018KYPJ103

Details and patient eligibility

About

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).

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

posterior capsulotomy

Experimental group

Description:

Primary posterior capsulotomy will be performed to remove the primary posterior capsule opacification after posterior capsule polishing during phacoemulsification.

Treatment:

Procedure: posterior capsulotomy

Nd:YAG laser capsulotomy

Active Comparator group

Description:

Nd:YAG laser capsulotomy will be performed 1 month postoperative to remove the primary posterior capsule opacification.

Treatment:

Procedure: laser capsulotomy