The effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle closure glaucoma

Completed

Conditions: Primary angle closure glaucoma
Eye Diseases
Glaucoma

Registration Number: ISRCTN44464607

Lead Sponsor: HS Grampian

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 400

Inclusion Criteria

1. Both males and females, age >=50 years
2. Diagnosis: either one of the following two types of patients: (i) primary angle-closure glaucoma (PACG), or (ii) primary angle-closure (PAC) with intraocular pressure (IOP) >30 mm Hg
3. Newly diagnosed, i.e. either (i) untreated or (ii) under medical treatment for 6 months or less
4. Angle closure (iridotrabecular contact) in 180 degrees or more
5. Patient must be phakic in the affected eye(s)
6. Written informed consent obtained

Exclusion Criteria

1. Advanced glaucoma in the potentially eligible eye as determined by either: (i) visual field loss (mean deviation worse than -15dB) or (ii) cup-disc-ratio >0.9
2. Previously diagnosed acute angle closure attack in the potentially eligible eye
3. Increased surgical risk: e.g., corneal opacity, Fuch's endothelial dystrophy, pseudoexfoliation, previous vitreo-retinal surgery, not able to be positioned to undergo standard technique
4. Symptomatic cataract in either eye
5. Previous cataract surgery or laser iridotomy in study eye
6. Axial length <19 mm (nanophthalmos)
7. Secondary angle closure glaucoma
8. History of retinal ischaemia, macular oedema or wet age-related macular degeneration
9. Medically unfit for surgery or for completion of the trial

Removed from the protocol as of 04/11/10:
10. Life expectancy <3 years

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Patient-centred outcome: Health Status, assessed by the EQ-5D at 6, 12, and 24 months with the major outcome assessment at 36 months from the date of randomisation<br>2. Clinical outcome: IOP at 3 year final assessment <br>3. Economic outcome: Incremental cost per quality adjusted life year (QALY) gained with QALYs based on the responses to the EQ-5D

Secondary Outcome Measures