Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-10-30

Brief Summary

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phacoemulsification with insertion of EYHANCE IOL to improve near and intermediate vision

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Detailed Description

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insertion of new intraocular lens enhanced for intermediate vision

Conditions

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Presbyopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

patients undergoing cataract surgery are managed with phacoemulsification and insertion of Eyehance intraocular lens in order to improve their intermediate vision.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Assessment of intermediate vision, defocus curve

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.

Group Type OTHER

phacoemulsification

Intervention Type PROCEDURE

phacoemulsification with implantation of EYEHANCE IOL

Interventions

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phacoemulsification

phacoemulsification with implantation of EYEHANCE IOL

Intervention Type PROCEDURE

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).

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No