Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-02

Study Completion Date

2019-03-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Primary Angle Closure Glaucoma

NCT02964676

Glaucoma, Angle-Closure

UNKNOWN NA

Evaluation of Phacogoniotomy in Medically-controlled POAG

NCT06201455

Glaucoma, Open-Angle Cataract Complicated Goniotomy

RECRUITING NA

Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy

NCT04703712

Glaucoma, Angle-Closure

UNKNOWN NA

The Effectiveness of YAG Iridotomy in Preventing Peripheral Anterior Synechia After CLASS in Primary Open Angle Glaucoma

NCT04912362

Glaucoma, Open-angle

UNKNOWN NA

Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma

NCT04878458

Glaucoma, Angle-Closure

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Cataract Aphakic Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Retrospective,consecutive,nonrandomized comparative trial with historical control

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PPI group

cataract extraction surgery with prophylactic peripheral iridectomy

Group Type EXPERIMENTAL

PPI group

Intervention Type PROCEDURE

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

historical control group

cataract extraction surgery

Group Type ACTIVE_COMPARATOR

cataract extraction

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PPI group

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

Intervention Type PROCEDURE

cataract extraction

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No