NCT05430295

Visual Acuity After Using A New Monofocal Intraocular Lens Compared To Standard Monofocal Lens

Distance And Intermediate Visual Acuity After Phacoemulsification Using A New Generation Monofocal Intraocular Lens Compared To Standard Monofocal Intraocular Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. Twenty patients (20) were enrolled in this study 10 patients in each group. It was designed for comparison of uncorrected and best corrected distance and intermediate vision in patients whom implanted with monofocal Tecnis Eyhance or Tecnis 1-piece IOLs.

Detailed description

Purpose To determine the Uncorrected and best-corrected distance, and intermediate visual acuity in a new innovative monofocal intraocular lens compared with standard monofocal lens. Methods This is a prospective comparative interventional clinical study, that took place from January 2021 to November 2021. 40 eyes of Twenty patients (20) were enrolled in this study, patients who are candidates for cataract extraction by phacoemulsification were included in this study and underwent thorough preoperative examination and post-operative evaluation at 3 months after the 2nd eye operation, of distance, intermediate, near add, contrast sensitivity and incidence of photic phenomena using a printed questionnaire for evaluating this incidence and binocular defocus curves were analyzed.

Conditions

• Lenses, Intraocular

Interventions

Type	Name	Description
PROCEDURE	phacoemulsification	cataract extraction followed by bilateral implantation of Eyhance intraocular lens in 10 patients and bilateral implantation of Tecnis 1 piece IOL in 10 patients
PROCEDURE	monofocal intraocular lens implantation	implantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-08-01
• Completion: 2021-11-01
• First posted: 2022-06-24
• Last updated: 2022-09-27

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study