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

Conditions

Primary angle closure glaucoma Eye Diseases Glaucoma

Mehdi Javanbakht, Augusto Azuara‐Blanco, Jennifer Burr, Craig Ramsay, David Cooper et al. (8 authors)

BMJ Open2017-01-0131 citations

10.1136/bmjopen-2016-013254

Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial.

Azuara-Blanco A, Burr J, Ramsay C, Cooper D, Foster PJ, Friedman DS, Scotland G, Javanbakht M, Cochrane C, Norrie J, EAGLE study group.

2016-10-01335 citations

10.1016/s0140-6736(16)30956-4

The effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle-closure glaucoma (EAGLE): study protocol for a randomized controlled trial.

Azuara-Blanco A, Burr JM, Cochran C, Ramsay C, Vale L, Foster P, Friedman D, Quayyum Z, Lai J, Nolan W, Aung T, Chew P, McPherson G, McDonald A, Norrie J, Effectiveness in Angle-closure Glaucoma of Lens Extraction (EAGLE) Study Group.

2011-05-2349 citations

10.1186/1745-6215-12-133

Interventions

The participants will be randomly allocate to the following treatments: Intervention group: Early lens extraction with intraocular lens implantation Control group: Standard care (usually laser iridot

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 2. Clinical outcome: IOP at 3 year final assessment 3. Economic outcome: Incremental cost per quality adjusted life year (QALY) gained with QALYs based on the responses to the EQ-5D	—

Secondary

Measure	Time frame
The following will be assessed at 6, 12, and 24 months with the major outcome assessment at 36 months from the date of randomisation: 1. Patient-centred: Patient reported, using: 1.1. A glaucoma specific utility instrument (GPI) 1.2. A vision specific health profile measure (NEI-VFQ25) 2. Clinical: 2.1. Need for trabeculectomy 2.2. Progressive visual field loss 2.3. Best-corrected visual acuity (ETDRS) 2.4. Extension of angle closure (degrees of appositional and synechial angle closure) 2.5. Escalation of therapy 2.6. Number of anti-glaucoma medications 2.7. Intolerance of medications 2.8. Incidence of acute attacks of angle closure 3. Economic: Costs will be based on resource use data. Costs to the NHS and patients: 3.1. Use of health services for glaucoma related events or treatments 3.2. Patient costs (treatments, spectacles, travel to health services, sick leave) 3.3. Need for alternative management for glaucoma (e.g., surgery, drugs) 3.4. Other use of health services: visits to i) GP, ii) nurse, iii) optometrists	—

Measure

Time frame

The following will be assessed at 6, 12, and 24 months with the major outcome assessment at 36 months from the date of randomisation: 1. Patient-centred: Patient reported, using: 1.1. A glaucoma specific utility instrument (GPI) 1.2. A vision specific health profile measure (NEI-VFQ25) 2. Clinical: 2.1. Need for trabeculectomy 2.2. Progressive visual field loss 2.3. Best-corrected visual acuity (ETDRS) 2.4. Extension of angle closure (degrees of appositional and synechial angle closure) 2.5. Escalation of therapy 2.6. Number of anti-glaucoma medications 2.7. Intolerance of medications 2.8. Incidence of acute attacks of angle closure 3. Economic: Costs will be based on resource use data. Costs to the NHS and patients: 3.1. Use of health services for glaucoma related events or treatments 3.2. Patient costs (treatments, spectacles, travel to health services, sick leave) 3.3. Need for alternative management for glaucoma (e.g., surgery, drugs) 3.4. Other use of health services: visits to i) GP, ii) nurse, iii) optometrists

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Countries

China, Hong Kong, Malaysia, Singapore, United Kingdom

Outcome results

None listed