Status:
NOT_YET_RECRUITING
Outcomes of High Vs Physiological Intraocular Pressure During Cataract Surgery Using ACTIVE SENTRY
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Cataract
Cataract Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cataract surgery is a widely performed procedure across the world that helps restore vision in many patients suffering from cataracts. Irrigation is an essential component of the surgery. Fluid is con...
Detailed Description
Cataract surgery is a widely performed procedure across the world that helps restore vision in many patients suffering from cataracts. The surgery has known many improvements across time and continues...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06611670
Start Date
October 1 2024
End Date
March 1 2025
Last Update
September 25 2024
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