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

• Sponsor: Kasr El Aini Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05430295
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lenses, Intraocular	Procedure: phacoemulsification; Procedure: monofocal intraocular lens implantation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a prospective comparative interventional clinical study,This is a prospective comparative interventional clinical study,
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Distance And Intermediate Visual Acuity After Phacoemulsification Using A New Generation Monofocal Intraocular Lens Compared To Standard Monofocal Intraocular Lens
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Aug 1, 2021
• Actual Study Completion Date: Nov 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Contrast sensitivity [3 months post operative]

   Contrast sensitivity was measured using Pelli Robson illuminated chart at 1m

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasraliany Hospital	Giza		Egypt	11555

Sponsors and Collaborators

• Kasr El Aini Hospital

Investigators

• Study Director: yehia Salaheldin, PhD, Cairo University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 26, 2022

More Information

Publications

None provided.

• Responsible Party: Rokaya Emad Radwan, ophthalmology resident, Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT05430295
• Other Study ID Numbers: MS-239-2021
• First Posted: Jun 24, 2022
• Last Update Posted: Jun 24, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Rokaya Emad Radwan, ophthalmology resident, Kasr El Aini Hospital: intraocular lens; intermediate vision; contrast sensitivity; monofocal

Study Results

No Results Posted as of Jun 24, 2022