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

NCT05430295 | Completed DMC FDA Device

• 1 other identifier: MS-239-2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lenses, Intraocular

Keywords

intraocular lens; intermediate vision; contrast sensitivity; monofocal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Contrast sensitivity

  3 months post operative

Study Arms (2)

Eyhance intraocular lens

ACTIVE COMPARATOR

10 patients bilaterally implanted with Eyhance intraocular lens

Procedure: phacoemulsification; Procedure: monofocal intraocular lens implantation

Tecnis 1 piece intraocular lens

ACTIVE COMPARATOR

10 patients bilaterally implanted with Tecnis 1 piece intraocular lens

Procedure: phacoemulsification; Procedure: monofocal intraocular lens implantation

Interventions

phacoemulsification PROCEDURE

cataract extraction followed by bilateral implantation of Eyhance intraocular lens in 10 patients and bilateral implantation of Tecnis 1 piece IOL in 10 patients

Also known as: cataract extraction

Eyhance intraocular lens; Tecnis 1 piece intraocular lens

monofocal intraocular lens implantation PROCEDURE

implantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery

Eyhance intraocular lens; Tecnis 1 piece intraocular lens

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasraliany Hospital

Giza, 11555, Egypt

Location

MeSH Terms

Interventions

Phacoemulsification; Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• yehia Salaheldin, PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ophthalmology resident

Model Details: This is a prospective comparative interventional clinical study,

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: June 24, 2022
• Study Start: January 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)