Search / Trial NCT06611670

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

Trial Information

Current as of December 21, 2024

Not yet recruiting

Keywords

Active Sentry Cataract Surgery Cataracts High Intra Ocular Pressure Central Corneal Thickness Intraocular Pressure Phacoemulsification Safety Profile Physiological Iop

ClinConnect Summary

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 to do so. Irrigation is an essential component of the surgery. Fluid is constantly being circulated to help regulate temperature as heat is generated with the use of ultrasound energy, to minimize tissue trauma, and to create an intraocular pressure sufficient to keep the anterior chamber stable. In parallel, aspiration brings the components of the cataract closer to the surgical instrument. A...

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.

Trial Officials

Samir Jabbour, MD,CM,FRCSC

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

About Centre Hospitalier De L'université De Montréal (Chum)

The Centre Hospitalier de l'Université de Montréal (CHUM) is a leading academic health institution in Canada, dedicated to advancing patient care through innovative research and clinical excellence. As a prominent sponsor of clinical trials, CHUM is committed to leveraging its multidisciplinary expertise and state-of-the-art facilities to facilitate groundbreaking studies that enhance medical knowledge and improve health outcomes. Collaborating with a network of healthcare professionals and researchers, CHUM fosters a rigorous research environment that prioritizes patient safety, ethical standards, and scientific integrity, positioning itself at the forefront of medical advancements.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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