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Laser Iridotomy Versus Phacoemulsification in Acute Angle Closure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00350428
First Posted: July 10, 2006
Last Update Posted: October 24, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Singapore National Eye Centre
  Purpose
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.

Condition Intervention
Angle Closure Glaucoma Procedure: Laser Preipheral Iridotomy and phacoemulsification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Angle Closure: Laser Iridotomy Versus Phacoemulsification Study (ACLIPS)- A Study of Acute Primary Angle Closure Glaucoma Comparing Two Treatment Modalities: Laser Peripheral vs Phacoemulsification With Posterior Intraocular Lens Implant

Resource links provided by NLM:


Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 70
Study Start Date: October 2001
Estimated Study Completion Date: October 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350428


Locations
Singapore
Singapore National Eye Centre
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
Principal Investigator: Steve Seah, FRCS (Ed) Singapore National Eye Centre
  More Information

ClinicalTrials.gov Identifier: NCT00350428     History of Changes
Other Study ID Numbers: R221/13/2001
SQGL05
First Submitted: July 7, 2006
First Posted: July 10, 2006
Last Update Posted: October 24, 2006
Last Verified: October 2004

Keywords provided by Singapore National Eye Centre:
Acute primary angle closure
Laser preipheral iridotomy
Phacoemulsification

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases