Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

NCT03610295 | Completed DMC

• 1 other identifier: 2018KYPJ091
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• The rate of aphakic angle-closure glaucoma

  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.

  18-49 months

Secondary Outcomes (2)

• The rate of iris posterior synechia

  18-49 months

• The rate of visual axis opacity

  18-49 months

Study Arms (2)

PPI group

EXPERIMENTAL

cataract extraction surgery with prophylactic peripheral iridectomy

Procedure: PPI group

historical control group

ACTIVE COMPARATOR

cataract extraction surgery

Procedure: cataract extraction

Interventions

PPI group PROCEDURE

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

PPI group

cataract extraction PROCEDURE

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

historical control group

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (2)

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Zhongshan Ophthalmic Center, Sun Yet-san University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Yizhi Liu, PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor,director of Zhongshan Ophthalmic Center

Model Details: Retrospective,consecutive,nonrandomized comparative trial with historical control

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 1, 2018
• Study Start: August 2, 2018
• Primary Completion: March 5, 2019
• Study Completion: March 5, 2019
• Last Updated: March 12, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)