Clinical trial NCT03701139: Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification.
Official title: Phacoemulsification Combined With Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Posterior Capsule Opacification
Keywords: phacoemulsification
cataract
primary posterior capsule opacification
posterior capsulotomy
randomized controlled trial
Nd:YAG laser capsulotomy
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: LogMAR visual acuity 1 month postoperatively
timeFrame: 1 month
Secondary outcomes:
measure: Dysfunctional lens index (DLI)
timeFrame: 3 months
measure: Internal higher order aberration (HOAs)
timeFrame: 3 months
measure: Object scatter index (OSI)
timeFrame: 3 months
measure: Modulation transfer function cut off (MTF cut off)
timeFrame: 3 months
measure: Strehl ratio (SR)
timeFrame: 3 months
measure: Predicted visual acuity (PVA) with contrasts of 100%, 20% and 10%
timeFrame: 3 months
measure: Rate of ocular hypertension
timeFrame: 3 months
measure: Rate of ocular macular edema
timeFrame: 3 months
measure: Rate of retinal detachment
timeFrame: 3 months
measure: Rate of intraocular lens damage
timeFrame: 3 months
measure: Visual-functioning index 7 score
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthamic Center,Sun Yet-san University
name: Yizhi Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: