Laser Iridotomy Versus Surgical Iridectomy in Early Angle Closure

Not Applicable

• Conditions: Intraocular Pressure Changes; Peripheral Anterior Synechiae Increasing
• Interventions: Procedure: Surgical Iridectomy; Procedure: Laser Iridotomy

• Registration Number: NCT01468103
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This is a randomized controlled clinical trial to compare laser peripheral iridotomy(LPI) and surgical peripheral iridectomy. Subjects of primary angle closure suspect, primary angle closure will be randomized to undergo LPI or SPI. Subjects are proposed to be followed up for 3 years.

Detailed Description

The following will be studied:

1. To evaluate the safety of these two techniques for the treatment of angle closure.

2. To compare the anterior chamber reaction and IOP changes post surgery.

3. TO establish the UBM/ASOCT chamber angle parameters changes pre and post surgery.

4. To assess the development of PAS.

Study Timeline

• Study Start: 2009-08
• Status Verified: 2011-11
• Study First Submitted: 2011-11-06
• Study First Submitted QC: 2011-11-08
• Last Update Submitted: 2011-11-08
• Study First Posted: 2011-11-09
• Last Update Posted: 2011-11-09
• Primary Completion: 2012-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. more than 50 years old
2. Diagnosis of either: Primary angle closure suspects, Primary angle closure in need of laser iridotomy or surgical iridectomy
3. Able to give Informed concent

Exclusion Criteria

1. Ophthalmic diseases other than glaucoma and cataract
2. pseudophakic or aphakic patients
3. inability to attend regular follow-up assessment or to give informed written consent
4. Secondary causes of angle closure e.g. subluxed lens, uveitis, trauma and neovascular glaucoma
5. Participating in another study
6. monocular patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PACS	Surgical Iridectomy	primary angle closure suspects
PACS	Laser Iridotomy	primary angle closure suspects
PAC	Surgical Iridectomy	primary angle closure
PAC	Laser Iridotomy	primary angle closure

Primary Outcome Measures

Name	Time	Method
intraocular pressure	3 years

Secondary Outcome Measures

Name	Time	Method
Angle assessment parameters	3 years	Angle assessment parameters,such as anterior chamber openning distance,are acquired by anterior segment optical coherence tomography.

Trial Locations

Locations (1)

ZhongShan Ophthalmic Center; 🇨🇳 GuangZhou, Guang Dong Province, China