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 |
| Secondary identifying numbers | EME 09/800/26 (as of 15/07/2010, previously MRC: G0701604) |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Augusto Azuara-Blanco
Scientific
Scientific
The Eye Clinic
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
Study information
| Study design | Multinational randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be downloaded from https://viis.abdn.ac.uk/HSRU/eagle/DownloadDefault.aspx |
| 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 hypothesis | 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 |
| Condition | 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 | 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 outcome measures | 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 |
| Overall study start date | 01/11/2008 |
| Overall study end date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 400 - The trial aims to recruit half of the participants in the UK (n = 200) and the other half in Hong Kong, Malaysia, Singapore and China combined (n = 200). |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/11/2008 |
| Recruitment end date | 31/12/2014 |
Locations
Countries of recruitment
- China
- Hong Kong
- Malaysia
- Scotland
- Singapore
- United Kingdom
Study participating centre
Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom
AB25 2ZN
United Kingdom
Sponsor information
NHS Grampian
Government
Government
Research and Development Office
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
| Website | http://www.nhsgrampian.org/randd |
|---|
University of Aberdeen
University/education
University/education
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
Scotland
United Kingdom
| Website | www.abdn.ac.uk |
|---|
NHS Grampian
Not defined
Not defined
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
