Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema

Not Applicable

Completed

Conditions: Diabetic Macular Oedema

Interventions: Device: Ellex Integre NIR laser

Registration Number: NCT02181400

Lead Sponsor: University of Sydney

Brief Summary: This pilot study aims to establish that treatment with near infrared light (NIR) reduces diabetic macular oedema in patients suffering diabetic retinopathy by exerting a positive beneficial effect at retinal cellular level.

Detailed Description: This pilot study aims to establish that treatment with near infrared light (NIR) reduces diabetic macular oedema in patients suffering diabetic retinopathy by exerting a positive beneficial effect at retinal cellular level.

Diabetic retinopathy is a common cause of severe loss of vision and the most common cause of blindness in individuals between the ages of 20 and 65 years in developed countries.Swelling of the central retina or "macular oedema". Patients will be treated in an office clinic,three times a week for a treatment duration of 2 minutes per session, a total of 12 times over the duration of 4 weeks and will be assessed at 8 weeks to establish any change induced in retinal oedema. Safety follow up will be assessed at 3 and 6 months post treatment.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

Inclusion Criteria

Diabetic Macular Oedema with centre involving thickness of >300µm
Age >= 18 years
Diagnosis of diabetes mellitus
Best corrected visual acuity of 6/9 to 6/60 (letters 77- 33)
Intraocular pressure 6 to 25 mmHg
Written informed consent has been obtained.

Exclusion Criteria

a) Known allergy to agents used in the study eg. fluorescein b) Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using reliable means of contraception. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilised c) Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion) d) Macular oedema due to other causes e) An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy or substantial premacular fibrosis) f) Treatment with intravitreal triamcinolone acetonide (IVTA) within the last 6 months or peribulbar triamcinolone within the last 3 months, or anti vascular endothelial growth factor (VEGF) drugs: ranibizumab and aflibercept, within the last 2 months.

g) Cataract surgery within the last 3 months h) Retinal laser treatment within the last 4 months i) Media opacity including cataract that already precludes adequate macular photography or cataract that is likely to require surgery within 6 months j) Intercurrent severe disease such as septicaemia, any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social) k) History of chronic renal failure requiring dialysis or renal transplant l) Blood pressure >180/100 m) Patient has a condition or is in a situation that in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIR laser treatment 100mW/cm2 dose	Ellex Integre NIR laser	The Ellex Integre NIR Laser dose of 100 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.
NIR Laser Treatment 25 miiliwatts (mW)/cm2 dose	Ellex Integre NIR laser	The Ellex Integre NIR (near Infrared Light) Laser dose of 25 milliwats(mW)/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.
NIR laser treatment 200mW/cm2 dose	Ellex Integre NIR laser	The Ellex Integre NIR (near Infrared Light) Laser dose of 200 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography( OCT) at One Month	Change from baseline in central macular thickness at one month	Change in measurement( in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography( OCT)
Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography (OCT) at Two Months	Change from baseline central macular thickness at two months	Change in measurement (in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography (OCT)
Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at One Month.	Change from baseline total macular volume at one month	The change in total macular volume was taken as the difference between the total macular volume as measured by Spectral Domain Optical Coherence Tomography at 1 month and the total macular volume at baseline
Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at Two Months.	Change from baseline total macular volume as measured by OCT at two months	The change in total macular volume was taken as the difference between the total macular volume as measured by Spectral Domain Optical Coherence Tomography at 2 month and the total macular volume at baseline

Secondary Outcome Measures

Name	Time	Method
Change in Logmar Best Corrected Visual Acuity (BCVA) at One Month.	Change from baseline BCVA measured at one month	Change in Logmar Best corrected visual acuity (BCVA) from 1 month to that measured at baseline
Change in Logmar Best Corrected Visual Acuity (BCVA) at Two Months	Change from baseline BCVA measured at two months	Change in Logmar Best corrected visual acuity (BCVA) from 2 month to that measured at baseline