Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT03610295

Collaborator

(none)

Enrollment

Locations

Arms

7.1

Actual Duration (Months)

43.5

Patients Per Site

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Cataract Aphakic Glaucoma	Procedure: PPI group Procedure: cataract extraction	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

87 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Retrospective,consecutive,nonrandomized comparative trial with historical controlRetrospective,consecutive,nonrandomized comparative trial with historical control

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Novel Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma After Congenital Cataract Surgery

Actual Study Start Date :

Aug 2, 2018

Actual Primary Completion Date :

Mar 5, 2019

Actual Study Completion Date :

Mar 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PPI group cataract extraction surgery with prophylactic peripheral iridectomy	Procedure: PPI group The patients underwent cataract extraction, posterior capsulotomy, anterior vitrectomy combined with prophylactic peripheral iridectomy.
Active Comparator: historical control group cataract extraction surgery	Procedure: cataract extraction The patients underwent cataract extraction, posterior capsulotomy combined with anterior vitrectomy and leave the iris intact.

Arm

Intervention/Treatment

Experimental: PPI group

cataract extraction surgery with prophylactic peripheral iridectomy

Procedure: PPI group

The patients underwent cataract extraction, posterior capsulotomy, anterior vitrectomy combined with prophylactic peripheral iridectomy.

Active Comparator: historical control group

cataract extraction surgery

Procedure: cataract extraction

The patients underwent cataract extraction, posterior capsulotomy combined with anterior vitrectomy and leave the iris intact.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong	China	510060
2	Zhongshan Ophthalmic Center, Sun Yet-san University	Guangzhou	Guangdong	China	510060