Status:
WITHDRAWN
Sub-threshold Photocoagulation of Diabetic Macular Oedema
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
Topcon Corporation
Optos, PLC
Conditions:
Diabetic Macular Oedema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Topcon's Endpoint Management (EM) is a new software from the Pascal® laser which allows us to decrease the intensity of the burns (invisible burns) showing some landmarks with normal intensity so the ...
Detailed Description
Diabetic macular oedema (DMO) remains the most common cause of visual loss in diabetic patients and affects around 29% of diabetic patients with 20 or more years of disease. The Early Treatment Diabet...
Eligibility Criteria
Inclusion
- Patient-eligibility
- Inclusion criteria:
- Older than 18 years of age
- Male or female patients with diabetes mellitus type I or type 2 who meet the WHO or ADA criteria for diabetes
- Able to give informed consent
- Study Eye eligibility
- Inclusion criteria:
- ETDRS visual acuity equivalent to 35 letters or better (Snellen equivalent 20/200 or better)
- The patient must have non-proliferative diabetic retinopathy (NPDR) with diffuse macular oedema
- Mean average central retinal thickness at least 300 microns as measured by Deep Range Imaging Optical Coherence Tomography (DRI -OCT) scans
- Adequate pupil dilatation and clear media to perform wide-field colour, red-free imaging and fundus fluorescein angiography (WF-FFA), wide-field fundus autofluorescence imaging (WF-AF) and DRI-OCT
- Ability to perform accurate Humphmrey visual field test
Exclusion
- Patient-eligibility
- Exclusion criteria:
- History of chronic renal failure or renal transplant for diabetic nephropathy
- Recent (last 6 months) or on-going poor glycaemic control. H1Ac greater than 10.0mg/dL
- Creatinine greater than 1.2 mg/dL
- HDL equal to or greater than 40 mg/dL
- Uncontrolled hypertension. Blood pressure greater or equal to 180/110 mmHg
- Patient is unavailable for follow-up visits
- Pregnant women or breast-feeding females
- Study Eye eligibility
- Exclusion criteria:
- Lens opacity that could influence vision and results
- Proliferative Diabetic Retinopathy.
- Any surgical or non-retinal laser treatment to the study eye within 2 months
- Narrow drainage angles with raised intraocular pressure and angle closure glaucoma.
- Planned YAG peripheral iridotomy
- Previous retinal laser photocoagulation, intraocular drug therapy, or macular laser treatment to treatment eye in last year
- Vitreomacular traction determined clinically and / or OCT, which in the opinion of the investigator, contributes to macular edema (associated or cause a detachment of the fovea) and prevents the improvement with treatment.
- Atrophy / scar / fibrosis involving the center of the macula, including evidence of atrophy treated with laser within 200 microns of the FAZ.
- Any previous ocular condition that may be associated with a risk of macular edema
- Important known allergies to sodium fluorescein dye used in angiography.
- 12\. Active lid or adnexal infection 13. Planned intra-ocular surgery within one year
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02309476
Start Date
October 1 2012
End Date
December 1 2015
Last Update
March 17 2020
Active Locations (1)
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1
Central Manchester Foundation Trust
Manchester, England, United Kingdom, M13 9WL