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Retinal Oximtery Following Treatment for Diabetic Maculopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by East Kent Hospitals University NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
NISHAL PATEL, East Kent Hospitals University NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01549132
First received: March 6, 2012
Last updated: March 8, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by East Kent Hospitals University NHS Foundation Trust:

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
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.

Criteria

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
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

Contacts
Contact: NISHAL PATEL, MD FRCOPHTH PATEL nishal.patel@ekht.nhs.uk
Contact: ART ATIONU ART.ATIONU@ekht.nhs.uk

Sponsors and Collaborators
East Kent Hospitals University NHS Foundation Trust
Investigators
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 November 25, 2014