Retinal Oximtery Following Treatment for Diabetic Maculopathy

NCT01549132 | Completed

• 1 other identifier: EKHT RETINAL RESEARCH UNIT
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetic Maculopathy

Keywords

Clinically significant macular oedema; Retinal Oximetry; Spectral imaging; Retinal Laser therapy; Intravitreal Anti-VEGF Injection therapy

Outcome Measures

Primary Outcomes (1)

• Retinal oximetry differences in patients with sight threatening diabetic macular oedema after treatment

  Does retinal oxygen levels in small blood vessels as measured by spectral imaging photography using the oxymap device at the centre of the retina (macula) differ in diabetic retinopathy in sight threatening disease?

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• East Kent Hospitals University NHS Foundation Trust: lead

Study Officials

• NISHAL PATEL, MD FRCOPHTH

  CONSULTANT OPHTHALMOLOGIST

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2014
• Last Updated: September 15, 2023

Record last verified: 2023-09