Clinical trial NCT03610295: Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma
Official title: A Novel Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma After Congenital Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Cataract
Aphakic Glaucoma
Keywords: congenital cataract
prophylactic peripheral iridectomy
aphakic angle-closure glaucoma
aphakic open-angle glaucoma
iris posterior synechia
visual axis opacity
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 87
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Retrospective,consecutive,nonrandomized comparative trial with historical control
Primary purpose: PREVENTION

Brief summary: This is a retrospective, nonrandomized comparative trial with historical control to investigate the safety and efficacy of a novel progressive grasping peripheral iridectomy (PGPI) surgical method in preventing aphakic angle-closure glaucoma (AACG) following congenital cataract surgery.

Detailed description: Aphakic angle-closure glaucoma (AACG) following congenital cataract surgery is a common and serious complication which can be prevented by prophylactic peripheral iridectomy (PPI). However, it is difficult to perform routine PPI via scleral tunnel incision especially when the pupil is dilated. Here, the investigators designed a novel progressive grasping peripheral iridectomy (PGPI) surgical method which can ensure the accurate iridectomy position and minimize the complication. The aim of this study is to assess the safety and efficacy of the PGPI in preventing AACG following congenital cataract surgery.

This is a retrospective, nonrandomized comparative trial with historical control. The congenital cataract patients performed with cataract extraction combined with PPI (PPI group) and the patients performed with cataract extraction alone and leaving the iris intact (historical control group) were enrolled and a retrospective medical chart review was conducted. The IOP, anterior chamber depth, corneal clarity, patency of peripheral iridectomy opening, and the rate of AACG, iris posterior synechia (IPS) and visual axis opacity (VAO) were compared between two groups.

Eligibility criteria: Inclusion Criteria:

1. patients less than 2 years old;
2. patients performed with congenital cataract surgery with or without PPI;
3. patients with routine follow-up at ZOC.

Exclusion Criteria:

1. patients with IOP ≥21 mm Hg or with congenital glaucoma or with a family history of glaucoma;
2. patients with keratopathy, retinopathy, ocular trauma, radiation therapy or intraocular surgery;
3. patients associated with other congenital ocular anomalies, such as anterior segment dysgenesis, microcornea/microphthalmia, persistent fetal vasculature, lens dislocation and iridocoloboma;
4. patients with systemic diseases, such as Down's syndrome, Lowe syndrome, Stickler syndrome, maternal rubella syndrome or trisomy 13.

Primary outcomes:
measure: The rate of aphakic angle-closure glaucoma
timeFrame: 18-49 months
Secondary outcomes:
measure: The rate of iris posterior synechia
timeFrame: 18-49 months
measure: The rate of visual axis opacity
timeFrame: 18-49 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yet-san University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: