Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision

Study Overview
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Brief Summary
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phacoemulsification with insertion of EYHANCE IOL to improve near and intermediate vision

Detailed Description
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insertion of new intraocular lens enhanced for intermediate vision

Official Title
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Clinical Outcomes With a New Monofocal Intraocular Lens Enhanced for Intermediate Vision

Conditions
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Presbyopia

Intervention / Treatment
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* Procedure: phacoemulsification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: normal ocular examination apart from cataract. Exclusion Criteria: previous ocular surgery. ocular pathology or corneal abnormalities. endothelial cell count below 2000 cells/mm2. corneal astigmatism greater than 1.0 diopter (D) measured with Scheimpflug tomography (Sirius, CSO, Italy).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: patients undergoing cataract surgery are managed with phacoemulsification and insertion of Eyehance intraocular lens in order to improve their intermediate vision.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Assessment of intermediate vision, defocus curve<br>Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 4 m, 80 cm, and 40 cm. he binocular defocus curve: The binocular defocus curve was done to evaluate the functional range of vision. The curve was obtained while the patient wearing his distance correction to provide the best distance visual acuity in both eyes. The test was performed under photopic conditions (85 candelas/m2) using ETDRS charts at a distance of 4m with the introduction of defocusing lenses from +1.00 D to -4.00 D in 0.50 D steps. | Procedure: phacoemulsification<br>* phacoemulsification with implantation of EYEHANCE IOL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intermediate vision assessment | Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 80 cm . | 6 months postoperatively | 
| near vision assessment | Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 40 cm. | 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| defocus curve | The curve was obtained while the patient wearing his distance correction to provide the best distance visual acuity in both eyes. The test was performed under photopic conditions (85 candelas/m2) using ETDRS charts at a distance of 4m with the introduction of defocusing lenses from +1.00 D to -4.00 D in 0.50 D steps. | 6 months postoperatively |