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

Launched by MEDICAL UNIVERSITY INNSBRUCK · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how cataract surgery can be performed safely in patients with diabetes who also have diabetic retinopathy, a condition that can affect vision. The goal is to see if keeping the eye pressure close to normal during surgery can reduce damage to the eye. Participants in the study will undergo cataract surgery on both eyes but with different eye pressure levels: one eye will be operated on at normal pressure, while the other will be at a higher pressure. This study is designed to find out if this approach can help lower the risk of problems after surgery.

To be eligible for this trial, participants need to be between 50 and 85 years old, have diabetes managed with medication, and show specific signs of diabetic retinopathy. They should also need cataract surgery in both eyes. Participants will receive detailed information about the study and must agree to follow the procedures. It's important to note that the trial is currently active but not recruiting new participants. If you or a loved one are considering participating, it’s a good idea to discuss this with a healthcare provider who can provide guidance based on individual health needs.

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)