Laser Iridotomy Versus Surgical Iridectomy in Early Angle Closure

NCT ID: NCT01468103

Last Updated: 2011-11-09

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Intraocular Pressure Changes Peripheral Anterior Synechiae Increasing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PACS

primary angle closure suspects

Group Type EXPERIMENTAL

Surgical Iridectomy

Intervention Type PROCEDURE

Surgical Iridectomy is now widely used in our clinical.

Laser Iridotomy

Intervention Type PROCEDURE

alternative choice to surgical iridectomy

PAC

primary angle closure

Group Type EXPERIMENTAL

Surgical Iridectomy

Intervention Type PROCEDURE

Surgical Iridectomy is now widely used in our clinical.

Laser Iridotomy

Intervention Type PROCEDURE

alternative choice to surgical iridectomy

Interventions

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Surgical Iridectomy

Surgical Iridectomy is now widely used in our clinical.

Intervention Type PROCEDURE

Laser Iridotomy

alternative choice to surgical iridectomy

Intervention Type PROCEDURE

Other Intervention Names

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Peripheral Surgical Iridectomy Peripheral Laser Iridotomy

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Gao Xinbo

student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhang X Lan, MD

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

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ZhongShan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Gao Xinbo, MD

Role: primary

Other Identifiers

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19831105gaoxinbo

Identifier Type: -

Identifier Source: org_study_id