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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01549132
First Posted: March 9, 2012
Last Update Posted: March 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
NISHAL PATEL, East Kent Hospitals University NHS Foundation Trust
  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

Further study details as provided by NISHAL PATEL, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 6, 2012
First Posted: March 9, 2012
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by NISHAL PATEL, East Kent Hospitals University NHS Foundation Trust:
Clinically significant macular oedema
Retinal Oximetry
Spectral imaging
Retinal Laser therapy
Intravitreal Anti-VEGF Injection therapy