A Comparison of Standard Laser With Micropulse Laser for the Treatment of Diabetic Macular Oedema. (DIAMONDS)
Diabetic Macular Edema
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic macular oedema, Diabetic retinopathy
Eligibility Criteria
Inclusion Criteria:
Patients with diabetic retinopathy and centre involving DMO, as determined by using spectral domain optical coherence tomography (SD-OCT), in one or both eyes with:
- Central retinal subfield thickness of > 300 but < 400 microns as determined by SD-OCT due to diabetic macular oedema OR
- Central retinal subfield thickness of < 300 microns provided that intraretinal and/or subretinal fluid is present in the central subfield (central 1 mm) related to diabetic macular oedema AND
- Visual acuity of > 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent > 20/320)
- Amenable to laser treatment, as judged by the treating ophthalmologist
- Over 18 years of age
Exclusion Criteria:
Eyes of patients will not be included in the study if:
- The macular oedema is due to causes other than diabetic macular oedema such as epiretinal membrane, vitreomacular traction, vein occlusion, or others
- The eye is ineligible for macular laser treatment, as judged by the treating ophthalmologist
- The eye has DMO and central subfield retinal thickness (CST) of > 400 microns. Doc No: TM09-LB01 Protocol Version 3.0 Final_ 09/01/17 Page 16 of 34
- The eye has activeA proliferative diabetic retinopathy (PDR) requiring treatment.
- The eye has received intravitreal Anti- Vascular Endothelical Growth Factor (Anti-VEGF) therapy within the previous two months.
- The eye has received macular laser treatment within the previous 12 months.
- The eye has received intravitreal injection of steroids.
- The eye has received cataract surgery within the previous six weeks
- The eye has received panretinal photocoagulation within the previous 3 months The patient is
- Patients on pioglitazone and the drug cannot be stopped 3 months prior to entering into the trial and for the duration of the study
- The patient has chronic renal failure requiring dialysis or kidney transplant
- The patient has any other condition that in the opinion of the investigator would preclude participation in the study (such as unstable medical status or severe disease that would make it difficult for the patient to be able to complete the study)
- The patient has very poor glycemic control and started intensive therapy within the previous 3 months
- The patient will use an investigational drug during the study
Sites / Locations
- Belfast Health & Social Care Trust
- Bradford Royal Infirmary
- Bristol Eye Hospital
- Frimley Park Hospital
- Hull and East Yorkshire Hospital
- Hinchingbrooke Hospital
- King's College Hospital
- Moorefields Eye Hospital
- Manchester Eye Hospital
- James Cook University Hospital South Tees
- Newcastle Eye Hospital
- Oxford John Radcliffe Hospital
- Sheffield Eye Hospital
- City Hopsitals Sunderland
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Diode Subthreshold Micropulse Laser
Standard threshold laser (532 nm laser)
DSML is a relatively new laser technology aimed at minimising damage ("tissue-sparing") to choroid and retina but maintaining treatment efficacy by its selective effect on the retinal pigment epithelium (RPE). It is performed using laser that, instead of delivering a continuous-wave laser beam, as the standard laser, it provides very small, repetitive, low energy pulses of laser separated by a brief rest period. This rest period allows the tissue to cool down between laser pulses avoiding the increased tissue heat that would be produced by continuous laser and allowing the use of lower laser energy power to achieve an effect. The reduced heat produced in the tissue and the reduced energy power required for the treatment may reduce side effects.
Green-yellow argon laser photocoagulation at threshold levels has been used for many years as the standard laser for the treatment of many retinal disorders including DMO. The ETDRS demonstrated the efficacy of laser in preventing visual loss in patients with DMO.