Outcomes of High Vs Physiological Intraocular Pressure During Cataract Surgery Using ACTIVE SENTRY

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Sep 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of two different levels of eye pressure during cataract surgery. The study aims to compare the outcomes of surgeries done at a normal, lower eye pressure (physiological intraocular pressure) using a special tool called the Active Sentry, versus surgeries done at a higher pressure, which has been traditionally used. Researchers want to find out if maintaining lower eye pressure can lead to safer surgeries with fewer risks of complications, such as damage to the eye's surface and a more comfortable experience for patients.

To participate in this trial, volunteers should be between the ages of 65 and 74 and have cataracts in both eyes that are similar in severity. They should not have had previous eye surgeries or certain eye conditions, such as glaucoma or corneal disease. If eligible, participants can expect to undergo a standard cataract surgery while researchers monitor the effects of the different eye pressure levels during the procedure. This study is not yet recruiting participants, but it could lead to safer and more effective cataract surgeries in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • No prior ocular surgery including corneal refractive surgery
• • Bilateral visually significant cataract, similar in density (LOCS III grade 2+), undergoing uncomplicated cataract surgery
• • Equal dilated pupil size ≥6mm, no use of pupil expansion devices
• • Axial length 22-26mm, refractive error between -5.00D to +5.00D and cylinder ≤ 3.00D, normal K values \<47.00D
• • Axial eye length cannot vary by more than 0.4 mm between eyes of an individual patient
• • Normal CCT range 540µm ± 50
• Exclusion Criteria:
• • History of corneal disease or dystrophies
• • Media opacification for reasons other than cataract
• • Compromised zonular integrity or stability.
• • Retinal and retinal vascular pathologies, age-related macular degeneration
• • Glaucoma
• • Patients with uncontrolled systematic diseases, including hypertension, diabetes, systemic cardiovascular diseases, and hematological diseases.