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Completed

NCT Number: NCT03610295

Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

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.

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Key information

Age range

2 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PPI group

Procedure

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

Cataract Extraction

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2018
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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