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Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03610295
Enrollment
87
Registered
2018-08-01
Start date
2018-08-02
Completion date
2019-03-05
Last updated
2019-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphakic Glaucoma, Congenital Cataract

Keywords

congenital cataract, prophylactic peripheral iridectomy, aphakic angle-closure glaucoma, aphakic open-angle glaucoma, iris posterior synechia, visual axis opacity

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.

Interventions

PROCEDUREPPI group

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

PROCEDUREcataract extraction

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

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Retrospective,consecutive,nonrandomized comparative trial with historical control

Eligibility

Sex/Gender
ALL
Age
2 Months to 24 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The rate of aphakic angle-closure glaucoma18-49 monthsPupillary 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

MeasureTime frameDescription
The rate of iris posterior synechia18-49 monthsPostoperative 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 opacity18-49 monthsvisual axis opacification (VAO) refers to developing reopacification of the visual axis in the form of lens proliferation into the visual axis or pupillary membrane.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026