Retinal Oximtery Following Treatment for Diabetic Maculopathy
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Purpose
The investigators believe that oxygen saturation measurements in the retina may provide more information on how well the retina is working and may detect problems in the retina earlier than the fundus fluorescein angiography (FFA). This may be useful to an ophthalmologist so that they may identify abnormal areas of the retina and commence or change the treatment so that they may prevent irreversible blindness.
Most patients with clinically significant macular oedema and/or ischaemic diabetic retinopathy could have either laser or Intravitreal Anti-VEGF injection treatment provided they are counseled about the risks. It is known the Anti-VEGF injections reduce oedema and it is believed that laser treatment of the retina in this condition improves the oxygen supply to the retina and sometimes reverses the damage. It will be useful to take pictures of these treated eyes using the Oxymap spectral retinal camera(s) to see whether the investigators can detect a change in the oxygen saturation in the retina before and after treatment using our oxygen saturation methods.
| Condition |
|---|
|
Diabetic Maculopathy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Non-invasive Retinal Oximetry Using Oxymap in Patients With Diabetic Maculopathy Receiving Laser/Intravitreal Anti-VEGF Therapy |
| Estimated Enrollment: | 45 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
• Patients will be selected from the Ophthalmology clinics with all sites at East Kent Hospitals University Foundation NHS Trust. These patients will be selected non−randomly by the ophthalmology clinician involved in their care based whether their clinical diagnosis fulfils the inclusion criteria. The ophthalmologists who are seeing patients in the ophthalmology clinics will identify the patients fulfilling the inclusion criteria for this study.
Inclusion Criteria:
- Diabetic Retinopathy affecting the central retina (designated maculopathy)
- No contraindications to pupil dilation
- Ocular media sufficiently clear to enable retinal imaging
- Pupils which can be dilated (i.e not using miotic medication)
- Willingness to participate with the research study and formal consent obtained.
Exclusion Criteria:
- Narrow drainage angles or any other contraindication to being dilated.
- Dense cataracts or other ocular media opacities inhibiting a good view of the retina on fundoscopy
Contacts and Locations| Contact: NISHAL PATEL, MD FRCOPHTH | PATEL | nishal.patel@ekht.nhs.uk |
| Contact: ART ATIONU | ART.ATIONU@ekht.nhs.uk |
| Principal Investigator: | NISHAL PATEL, MD FRCOPHTH | CONSULTANT OPHTHALMOLOGIST |
More Information
No publications provided
| Responsible Party: | NISHAL PATEL, Consultant Ophthalmologist, East Kent Hospitals University NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01549132 History of Changes |
| Other Study ID Numbers: | EKHT RETINAL RESEARCH UNIT |
| Study First Received: | March 6, 2012 |
| Last Updated: | March 8, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by East Kent Hospitals University NHS Foundation Trust:
|
Clinically significant macular oedema Retinal Oximetry Spectral imaging Retinal Laser therapy Intravitreal Anti-VEGF Injection therapy |
ClinicalTrials.gov processed this record on May 16, 2013