Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision

May 25, 2021 updated by: magda torky, Dar Al Shifa Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

insertion of new intraocular lens enhanced for intermediate vision

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Kuwait
      • Kuwait, Kuwait
        • Recruiting
        • Daralshifa hospital
        • Contact:
          • magda torky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Procedure: phacoemulsification
phacoemulsification with implantation of EYEHANCE IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intermediate vision assessment
Time Frame: 6 months postoperatively
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
Time Frame: 6 months postoperatively
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
Time Frame: 6 months postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dar Al Shifa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

July 30, 2021

Study Completion (Anticipated)

October 30, 2021

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02282021065725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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