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

NCT ID: NCT05430295

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-11-01

Brief Summary

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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

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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

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Lenses, Intraocular

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a prospective comparative interventional clinical study,
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Eyhance intraocular lens

10 patients bilaterally implanted with Eyhance intraocular lens

Group Type ACTIVE_COMPARATOR

phacoemulsification

Intervention Type 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

monofocal intraocular lens implantation

Intervention Type PROCEDURE

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

Tecnis 1 piece intraocular lens

10 patients bilaterally implanted with Tecnis 1 piece intraocular lens

Group Type ACTIVE_COMPARATOR

phacoemulsification

Intervention Type 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

monofocal intraocular lens implantation

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

monofocal intraocular lens implantation

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

Intervention Type PROCEDURE

Other Intervention Names

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cataract extraction

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rokaya Emad Radwan

ophthalmology resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yehia Salaheldin, PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

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Kasraliany Hospital

Giza, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MS-239-2021

Identifier Type: -

Identifier Source: org_study_id

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