Micropulse diode vs conventional green laser treatment in clinically significant diabetic macular oedema
| ISRCTN | ISRCTN90646644 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90646644 |
| Secondary identifying numbers | MP1 |
- Submission date
- 25/07/2007
- Registration date
- 30/08/2007
- Last edited
- 28/09/2009
- 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 of protocol
Not provided at time of registration
Contact information
Dr Victor Chong
Scientific
Scientific
Laser and Retinal Research Unit
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
| victor@eretina.org |
Study information
| Study design | Prospective randomised double-masked controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Micropulse diode laser has been used for patients with clinically significant diabetic macular oedema. It has not been directly compared with the standard treatment with green laser. In this study, we are going to perform a prospective randomised double-masked controlled trial to compare these two treatment modalities. |
| Ethics approval(s) | South East London Ethical Committee, approved on 14 August 2003(ref: 07-03-159) |
| Health condition(s) or problem(s) studied | Diabetic macular oedema |
| Intervention | Micropulse diode vs conventional green laser treatment |
| Intervention type | Other |
| Primary outcome measure | Visual acuity at 12 months. |
| Secondary outcome measures | The following will be assessed at 12 months: 1. Contract sensitivity 2. Central retinal thickness 3. Visible laser scars in macula |
| Overall study start date | 01/01/2005 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Patients with clinically significant macular edema due to diabetes in at least one eye 2. Able to understand and consent to the study 3. Vision acuity on study eye better than 20/200 |
| Key exclusion criteria | 1. Ocular surgery within the past 6 months 2. Any laser surgery in the study eye 3. Any other ocular diseases in the study eye that can alter vision during the study period 4. Poor diabetic control with HBA1c >12 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Laser and Retinal Research Unit
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Sponsor information
King's College Hospital (UK)
University/education
University/education
Denmark Hill
London
SE5 9RS
England
United Kingdom
| victor.chong@kch.nhs.uk | |
"ROR" |
https://ror.org/01qz4yx77 |
Funders
Funder type
Government
Ophthalmic Fund within the King's College Hospital NHS Trust (UK)
No information available
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 | 01/10/2009 | Yes | No |
