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NCT05886283

Qualitative and Quantitative Endothelium Changes After Cataract Surgery: Ultrasound Phacoemulsification vs Nanolaser Technique

Completed NA Last updated 5 June 2023
What this trial tests

NA trial testing phacoemulsification in Effect of Cataract Surgery on Corneal Endothelium; About 2 Techniques in 74 participants. Completed in 30 December 2020.

Timeline
1 March 2017
Primary endpoint
31 May 2020
30 December 2020

Quick facts

Lead sponsorUniversity Tunis El Manar
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment74
Start date1 March 2017
Primary completion31 May 2020
Estimated completion30 December 2020
Sites1 location across Tunisia

Drugs / interventions tested

Conditions studied

Sponsor

University Tunis El Manar

Who can join

Adults 50 to 90, any sex, with Effect of Cataract Surgery on Corneal Endothelium; About 2 Techniques. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Purpose: The aim of this study was to evaluate corneal endothelial cell density and morphology, central corneal thickness, and best visual acuity using US phacoemulsification or Nanosecond laser technique. Setting: Department of ophthalmology, Nabeul, Tunisia. Design: Prospective cohort study. Methods: The study included eyes with nuclear cataract density grade 1, 2, 3, or 4 according to LOCS III, divided into two groups; Group 1 had conventional US, and group 2 had nanosecond laser. The Endothelial Cell Density (ECD), coefficient of variation (CoV) in cell size, percentage of hexagonal cells, central corneal thickness and best visual acuity were evaluated over 24 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Qualitative and quantitative endothelium changes after cataract surgery: ultrasound phacoemulsification vs. nanolaser technique.
    Zbiba W, Kharrat M, Sayadi S, Kallel Z, et al · · 2023 · PMID 37809334 · DOI 10.3389/fmed.2023.1097404

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