Status:

UNKNOWN

Argon Laser Peripheral Iridoplasty for Primary Angle Closure Glaucoma

Lead Sponsor:

Singapore National Eye Centre

Collaborating Sponsors:

National University Hospital, Singapore

Conditions:

Glaucoma

Eligibility:

All Genders

21+ years

Phase:

PHASE3

Brief Summary

Glaucoma is the leading cause of irreversible blindness worldwide. With ageing of the population, glaucoma morbidity will rise, causing increased health care costs and economic burden for a condition ...

Detailed Description

AIMS AND OBJECTIVES The primary aim of the study is to determine whether argon laser peripheral iridoplasty (ALPI) is an effective treatment in terms of intraocular pressure (IOP) control for cases o...

Eligibility Criteria

Inclusion

  • Persistent narrow angle in the presence of a patent laser peripheral iridotomy. A narrow angle is defined as an angle width of 0-10º in 2 or more quadrants of either eye or where the pigmented trabecular meshwork is not visible in for 2 or more quadrants on gonioscopic examination
  • Intraocular pressure \> 21mmHg on or off topical medication at least four weeks following laser iridotomy
  • Intra ocular pressure \> 21 mm Hg after wash out regimen as described below for patients who are already on one medication and Iridotomy has been done at least 4 weeks ago.
  • Informed Consent
  • Age more than 21 years

Exclusion

  • Age less than 21 years
  • Secondary causes of angle closure like subluxed lens, uveitis, trauma and neovascular glaucoma
  • Presence of advanced sight-threatening glaucoma defined as vertical cup-disc ratio \> 0.9
  • Presence of significant synechial angle closure with \> 6 clock hours of peripheral anterior synechiae (defined as abnormal adhesions of the iris to the angle that are at least half a clock hour in width and be at least to the anterior trabecular meshwork or higher on indentation gonioscopy)
  • Cataract that is deemed significant enough to require surgery during the course of the trial or that makes field testing or optic disc imaging not technically possible- visual acuity less than 20/40 due to any type of cataract.
  • Corneal endothelial cell count less than 1000 cells/mm2
  • Corneal abnormalities or infection
  • Previous intraocular surgery
  • Use of contact lens
  • Chronic use of topical or systemic steroids
  • Participation in another therapeutic drug study within the last 30 days
  • Severe health problems precluding follow-up such as end-stage heart disease, kidney disease, respiratory disease, or cancer and life expectancy less than one year.

Key Trial Info

Start Date :

September 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT00980473

Start Date

September 1 2007

Last Update

June 17 2011

Active Locations (1)

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1

Singapore National Eye Centre

Singapore, Singapore, 168751