Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

Overview

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.

Full Title of Study: “A Novel Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma After Congenital Cataract Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 5, 2019

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.

Interventions

  • Procedure: PPI group
    • The patients underwent cataract extraction, posterior capsulotomy, anterior vitrectomy combined with prophylactic peripheral iridectomy.
  • Procedure: cataract extraction
    • The patients underwent cataract extraction, posterior capsulotomy combined with anterior vitrectomy and leave the iris intact.

Arms, Groups and Cohorts

  • Experimental: PPI group
    • cataract extraction surgery with prophylactic peripheral iridectomy
  • Active Comparator: historical control group
    • cataract extraction surgery

Clinical Trial Outcome Measures

Primary Measures

  • The rate of aphakic angle-closure glaucoma
    • Time Frame: 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 Measures

  • The rate of iris posterior synechia
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 2 Months

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yizhi Liu, Clinical Professor,director of Zhongshan Ophthalmic Center – Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Overall Official(s)
    • Yizhi Liu, PhD, Principal Investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.