Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

Not Applicable

Completed

• Conditions: Congenital Cataract; Aphakic Glaucoma
• Interventions: Procedure: cataract extraction; Procedure: PPI group

• Registration Number: NCT03610295
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-01
• Study Start: 2018-08-02
• Status Verified: 2019-03
• Primary Completion: 2019-03-05
• Study Completion: 2019-03-05
• Last Update Submitted: 2019-03-09
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
historical control group	cataract extraction	cataract extraction surgery
PPI group	PPI group	cataract extraction surgery with prophylactic peripheral iridectomy

Primary Outcome Measures

Name	Time	Method
The rate of aphakic angle-closure glaucoma	18-49 months	Pupillary block with subsequent closure of the filtration angle is the cause of early aphakic angle-closure glaucoma (AACG), which usually happens in the early postoperative period, generally within the first 6 months. AACG presents with elevated IOP (repeatedly \>25 mmHg), corneal edema, iris bombe, shallow anterior chamber, peripheral anterior synechia and angle closure.

Secondary Outcome Measures

Name	Time	Method
The rate of iris posterior synechia	18-49 months	Postoperative uveal inflammation can result in iris posterior synechia (IPS), referring to the synechia between iris and capsule around pupil. IPS is graded according to the range of the synechia. Grade 0: no synechia; Grade I: \<1 quadrant; Grade II: ≤2 quadrants and \>1 quadrant ; Grade III: ≤3 quadrants and \>2 quadrants; Grade IV: \>3 quadrants.
The rate of visual axis opacity	18-49 months	visual axis opacification (VAO) refers to developing reopacification of the visual axis in the form of lens proliferation into the visual axis or pupillary membrane.

Trial Locations

Locations (2)

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Zhongshan Ophthalmic Center, Sun Yet-san University; 🇨🇳 Guangzhou, Guangdong, China