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

Not Applicable

Completed

• Conditions: Lenses, Intraocular
• Interventions: Procedure: phacoemulsification; Procedure: monofocal intraocular lens implantation

• Registration Number: NCT05430295
• Lead Sponsor: Kasr El Aini Hospital

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.

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 Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-11-01
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-06-18
• Study First Posted: 2022-06-24
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-24
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eyhance intraocular lens	phacoemulsification	10 patients bilaterally implanted with Eyhance intraocular lens
Tecnis 1 piece intraocular lens	phacoemulsification	10 patients bilaterally implanted with Tecnis 1 piece intraocular lens
Eyhance intraocular lens	monofocal intraocular lens implantation	10 patients bilaterally implanted with Eyhance intraocular lens
Tecnis 1 piece intraocular lens	monofocal intraocular lens implantation	10 patients bilaterally implanted with Tecnis 1 piece intraocular lens

Primary Outcome Measures

Name	Time	Method
Uncorrected and best-corrected distance, and intermediate visual acuity.	3 months post operative	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.

Secondary Outcome Measures

Name	Time	Method
Contrast sensitivity	3 months post operative	Contrast sensitivity was measured using Pelli Robson illuminated chart at 1m

Trial Locations

Locations (1)

Kasraliany Hospital; 🇪🇬 Giza, Egypt