A prospective, randomised, double-masked, controlled trial of the treatment of diabetic maculopathy using diode micropulsed laser versus standard argon laser
| ISRCTN | ISRCTN66877546 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66877546 |
| Protocol serial number | N0013146051 |
| Sponsor | Department of Health |
| Funders | Guy's and St. Thomas' NHS Foundation Trust, Own account, NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 01/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr John Shilling
Scientific
Scientific
Ophthalmology
Ground Floor, South Wing (Block 7)
St. Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A prospective, randomised, double-masked, controlled trial of the treatment of diabetic maculopathy using diode micropulsed laser versus standard argon laser |
| Study objectives | Is the use of micropulsed diode laser application more effective than current argon laser in treatment of diabetic maculopathy? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Macular retinopathy |
| Intervention | Laser application in a grid/ focal pattern to patients with macula oedema secondary to diabetic retinopathy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Visual acuity, reduction of oedema by angiographic methods and use of optical coherence tomography. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | Adults with no other ocular pathology apart from diabetic maculopathy sample all are newly diagnosed patients |
| Key exclusion criteria | Patients with ocular pathology apart from diabetic maculopathy |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 01/05/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St. Thomas' Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
