Laser Iridotomy Versus Phacoemulsification in Acute Angle Closure

NCT00350428 | Completed

• 2 other identifiers: R221/13/2001SQGL05
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised controlled clinical trial to compare laser peripheral iridotomy (LPI) and primary phacoemulsification with intra-ocular lens implantation (phaco/IOL) in the treatment of acute primary angle-closure glaucoma (APACG). Following successful medical lowering of raised intra-ocular pressure (IOP) and control of intraocular inflammation, patients presenting to Singapore National Eye Centre and Singapore General Hospital with acute primary angle-closure glaucoma who meet the eligibility are randomised to one of the two treatment arms: laser peripheral iridotomy and primary phacoemulsification with intra-ocular lens implantation. These patients will be monitored closely for 2 years post-operatively.

Conditions

Angle Closure Glaucoma

Keywords

Acute primary angle closure; Laser preipheral iridotomy; Phacoemulsification

Outcome Measures

Primary Outcomes (3)

• Recurrence of APACG: Patients who develop a recurrence of symptoms of APACG. Treatment of recurrence will be decided by the ophthalmologist managing the patient.

• IOP lowering medication is required.

• Further glaucoma surgery is required.

Secondary Outcomes (3)

• Cataract surgery is required. Patients in the LPI group who develop significant progression of cataract during the follow-up period will be offered cataract extraction.

• No light perception

• Eyes become phthisical

Interventions

Laser Preipheral Iridotomy and phacoemulsification PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• APACG. In cases where both eyes are eligible, the right eye will be entered.
• IOP less than or equal to 30 mmHg within 24 hours of presentation and after initiation of medical treatment
• Significant cataract with best corrected visual acuity equal or less than 6/15
• Informed consent

You may not qualify if:

• Secondary causes of angle-closure e.g. subluxed lens, uveitis, trauma and neovascular glaucoma
• Intumescent cataract (phacomorphic glaucoma)
• Eyes with anterior chamber depth differing by more than 0.3 mm
• Eyes with no cataract
• Active ocular infection in either eye which would prevent surgery
• Female subjects who are pregnant, nursing or of childbearing potential and not using adequate contraception
• Participating in another study
• Previous intraocular eye surgery on the affected eye.
• Any medical condition which would be a contra-indication to surgery

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Steve Seah, FRCS (Ed)

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 7, 2006
• First Posted: July 10, 2006
• Study Start: October 1, 2001
• Study Completion: October 1, 2007
• Last Updated: October 24, 2006

Record last verified: 2004-10

Locations

SG (1)