Search / Trial NCT06617273

Cataract Surgery with Near Normal Eye Pressure in Patients with Diabetic Retinopathy

Launched by MEDICAL UNIVERSITY INNSBRUCK · Sep 24, 2024

Trial Information

Current as of October 04, 2024

Unknown status

Keywords

Diabetic Retinopathy Phacoemulsification Microincision Phacoemulsification Cataract Intraocular Pressure Active Anterior Chamber Pressure

Description

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Indication for immediate sequential bilateral microincision cataract surgery
  • 2. Diagnosis of Diabetes Mellitus treated with oral medication or insulin therapy and confirmed by HbA1c ≥6,5 %
  • 3. Presence of diabetic retinopathy grade ≥1 on the international clinical diabetic retinopathy (ICDR) severity scale
  • 4. LOCS 2-4 with no more than 1 grade difference between both eyes
  • 5. Male or female patient aged 50 - 85 years of age at time of consent
  • 6. Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature
  • Exclusion Criteria:
  • 1. Participation in another clinical trial within 30 days before pre-screening and throughout the trial
  • 2. Prior intraocular surgery of any type
  • 3. History of diabetic macular edema
  • 4. Presence of macular edema, defined as central retinal thickness of \>300 µm plus intraretinal or subretinal fluid on OCT within range of 1mm of foveal center
  • 5. Presence of any retinal or choroidal disease, other than diabetes, that could affect retinal thickness
  • 6. Known history of uveitis
  • 7. Documented use of systemic or topical steroid or other immunosuppressive medication within the last 3 months
  • 8. ACF \>10 ph/ms. ACF difference between right and left eye \> 4ph/ms
  • 9. Difference of DRP grading between right and left eye of more than 1 grade (ICDR)
  • 10. Inability to measure total macular volume due to, but not limed to, too dense cataract, vitreous bleeding
  • 11. Woman of childbearing potential (WOCBP) who is breastfeeding, has a positive urine pregnancy test, is not willing to undergo a urine pregnancy test upon entering or exiting the study, intends to become pregnant during the study, or does not agree to use adequate birth control methods for the duration of the study
  • 12. Patients in possession of an active implantable medical device (AIMD)

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Innsbruck, , Austria

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0