Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema
Diabetic Macular Oedema
Bottom Line
View on ClinicalTrials.gov: NCT02181400 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ellex Integre NIR laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Sydney
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography( OCT) at One Month |
-25.2; -29.9; -58.9 | 0.04 sig |
| PRIMARY Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography (OCT) at Two Months |
-52.5; -128.6; -114 | 0.04 sig |
| PRIMARY Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at One Month. |
0.1; 0; -0.3 | 0.12 |
| PRIMARY Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at Two Months. |
-0.2; 0.2; -0.2 | 0.32 |
| SECONDARY Change in Logmar Best Corrected Visual Acuity (BCVA) at One Month. |
4; 2; 6 | 0.02 sig |
| SECONDARY Change in Logmar Best Corrected Visual Acuity (BCVA) at Two Months |
4; -2; -3 | 0.49 |
Summary
Eligibility Criteria
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
-
Data sourced from ClinicalTrials.gov (NCT02181400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.