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

Study Overview
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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.

Official Title
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Distance And Intermediate Visual Acuity After Phacoemulsification Using A New Generation Monofocal Intraocular Lens Compared To Standard Monofocal Intraocular Lens

Conditions
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Lenses, Intraocular

Intervention / Treatment
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* Procedure: phacoemulsification
* Procedure: monofocal intraocular lens implantation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective comparative interventional clinical study,
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eyhance intraocular lens<br>10 patients bilaterally implanted with Eyhance intraocular lens | Procedure: phacoemulsification<br>* cataract extraction followed by bilateral implantation of Eyhance intraocular lens in 10 patients and bilateral implantation of Tecnis 1 piece IOL in 10 patients<br>* Other names: cataract extraction;Procedure: monofocal intraocular lens implantation<br>* implantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery<br>|
| Active Comparator: Tecnis 1 piece intraocular lens<br>10 patients bilaterally implanted with Tecnis 1 piece intraocular lens | Procedure: phacoemulsification<br>* cataract extraction followed by bilateral implantation of Eyhance intraocular lens in 10 patients and bilateral implantation of Tecnis 1 piece IOL in 10 patients<br>* Other names: cataract extraction;Procedure: monofocal intraocular lens implantation<br>* implantation of monofocal intraocular lens in the capsular bag at the end of phacoemulsification surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast sensitivity | Contrast sensitivity was measured using Pelli Robson illuminated chart at 1m | 3 months post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraocular lens, intermediate vision, contrast sensitivity, monofocal