Retinal Oximtery Following Treatment for Diabetic Maculopathy
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by NISHAL PATEL, East Kent Hospitals University NHS Foundation Trust.
Recruitment status was: Not yet recruiting
Information provided by (Responsible Party):
NISHAL PATEL, East Kent Hospitals University NHS Foundation Trust
First received: March 6, 2012
Last updated: March 8, 2012
Last verified: March 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Non-invasive Retinal Oximetry Using Oxymap in Patients With Diabetic Maculopathy Receiving Laser/Intravitreal Anti-VEGF Therapy
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||Child, Adult, Senior
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
• 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.
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549132
East Kent Hospitals University NHS Foundation Trust
||NISHAL PATEL, MD FRCOPHTH
||NISHAL PATEL, Consultant Ophthalmologist, East Kent Hospitals University NHS Foundation Trust
History of Changes
|Other Study ID Numbers:
EKHT RETINAL RESEARCH UNIT
|Study First Received:
||March 6, 2012
||March 8, 2012
Keywords provided by NISHAL PATEL, East Kent Hospitals University NHS Foundation Trust:
ClinicalTrials.gov processed this record on June 27, 2017
Clinically significant macular oedema
Retinal Laser therapy
Intravitreal Anti-VEGF Injection therapy