The effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle closure glaucoma
| ISRCTN | ISRCTN44464607 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44464607 |
| Protocol serial number | EME 09/800/26 (as of 15/07/2010, previously MRC: G0701604) |
| Sponsors | NHS Grampian, University of Aberdeen, NHS Grampian |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 22/08/2008
- Registration date
- 23/10/2008
- Last edited
- 16/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
The Eye Clinic
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multinational randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle closure glaucoma: a randomised controlled trial (EAGLE) |
| Study acronym | EAGLE (Effectiveness, in Angle-closure Glaucoma of Lens Extraction) |
| Study objectives | In patients with primary angle closure glaucoma (PACG), this study will compare the clinical and cost-effectiveness of early lens extraction surgery compared with standard care (usually laser iridotomy followed by a sequence of medical therapy, laser iridoplasty and trabeculectomy). |
| Ethics approval(s) | North of Scotland Research Ethics Committee 2, 09/10/2008, ref: 08/S0802/153 |
| Health condition(s) or problem(s) studied | Primary angle closure glaucoma |
| Intervention | 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 iridotomy followed , as necessary, by a sequence of medical therapy, laser iridoplasty and trabeculectomy) Total duration of follow-up: 3 years |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
The following will be assessed at 6, 12, and 24 months with the major outcome assessment at 36 months from the date of randomisation: |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
- China
- Hong Kong
- Malaysia
- Singapore
Study participating centre
AB25 2ZN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/05/2011 | Yes | No | |
| Results article | results | 01/10/2016 | Yes | No | |
| Other publications | economic evaluation | 13/01/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/01/2017: Publication reference added.
07/10/2016: Publication reference added.
18/04/2013: The overall trial end date was changed from 31/01/2014 to 31/12/2014.
04/11/2010: Taiwan was removed and China and Malaysia were added to the countries of recruitment. EAGLE was also transferred from MRC to the Efficacy and Mechanism Evaluation (EME) programme for post-award management on the 15/07/2010.