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

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.

Study Overview

• Status: Completed
• Conditions: Lenses, Intraocular
• Intervention / Treatment: Procedure: phacoemulsification; Procedure: monofocal intraocular lens implantation

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11555
    • Kasraliany Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 50-75 years old undergoing cataract surgery.
• Preoperative corneal astigmatism equal to or less than - 1.00 D.
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

• Visual potential of less than 0.63 due to ocular pathologies.
• Corneal astigmatism over -1.00 D cylinder.
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions).
• Capsule or zonular abnormalities that would affect postoperative centration or tilt of the lens and pseudoexfoliation syndrome.
• Macular degeneration, cystoid macular edema,Diabetic retinopathy, history of uveitis, optic nerve diseases, glaucoma and amblyopia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Eyhance intraocular lens; 10 patients bilaterally implanted with Eyhance intraocular lens	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; Other Names: cataract extraction; Procedure: monofocal intraocular lens implantation; implantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery
ACTIVE_COMPARATOR: Tecnis 1 piece intraocular lens; 10 patients bilaterally implanted with Tecnis 1 piece intraocular lens	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; Other Names: cataract extraction; Procedure: monofocal intraocular lens implantation; implantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected and best-corrected distance, and intermediate visual acuity.	Distance visual acuities were examined by ETDRS chart and intermediate and near visual acuity by Jaeger chart at 66 cm and 33 cm respectively.Measured values of the visual acuity were expressed in decimal values and converted to logMAR values.	3 months post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast sensitivity	Contrast sensitivity was measured using Pelli Robson illuminated chart at 1m	3 months post operative

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Study Director: yehia Salaheldin, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): August 1, 2021
• Study Completion (ACTUAL): November 1, 2021

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: June 18, 2022
• First Posted (ACTUAL): June 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 24, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: intraocular lens; intermediate vision; monofocal; contrast sensitivity
• Other Study ID Numbers: MS-239-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the data of the patients are kept in files with the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes