Visual Acuity After Using A New Monofocal Intraocular Lens Compared To Standard Monofocal Lens
NCT ID: NCT05430295
Last Updated: 2022-09-27
Study Results
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-01-01
2021-11-01
Brief Summary
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Eyhance intraocular lens
10 patients bilaterally implanted with Eyhance intraocular lens
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
monofocal intraocular lens implantation
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
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
monofocal intraocular lens implantation
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
monofocal intraocular lens implantation
implantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Preoperative corneal astigmatism equal to or less than - 1.00 D.
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria
* 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.
50 Years
75 Years
ALL
Yes
Sponsors
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Kasr El Aini Hospital
OTHER
Responsible Party
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Rokaya Emad Radwan
ophthalmology resident
Principal Investigators
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yehia Salaheldin, PhD
Role: STUDY_DIRECTOR
Cairo University
Locations
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Kasraliany Hospital
Giza, , Egypt
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MS-239-2021
Identifier Type: -
Identifier Source: org_study_id
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