Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision

Not Applicable

• Conditions: Presbyopia

• Registration Number: NCT04904887
• Lead Sponsor: Dar Al Shifa Hospital

Brief Summary

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

Detailed Description

insertion of new intraocular lens enhanced for intermediate vision

Study Timeline

• Study Start: 2020-11-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-25
• Last Update Submitted: 2021-05-25
• Study First Posted: 2021-05-27
• Last Update Posted: 2021-05-27
• Primary Completion: 2021-07-30
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
intermediate vision assessment	6 months postoperatively	Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 80 cm .
near vision assessment	6 months postoperatively	Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 40 cm.

Secondary Outcome Measures

Name	Time	Method
defocus curve	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.

Trial Locations

Locations (1)

Daralshifa hospital; 🇰🇼 Kuwait, Kuwait