Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision

NCT04904887 | Unknown

• 1 other identifier: 02282021065725
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• defocus curve

  6 months postoperatively

Study Arms (1)

Assessment of intermediate vision, defocus curve

OTHER

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

Interventions

phacoemulsification PROCEDURE

phacoemulsification with implantation of EYEHANCE IOL

Assessment of intermediate vision, defocus curve

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• normal ocular examination apart from cataract.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dar Al Shifa Hospital: lead

Study Sites (1)

Daralshifa hospital

Kuwait City, Kuwait

RECRUITING

MeSH Terms

Conditions

Presbyopia

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Central Study Contacts

Magda Torky

CONTACT

0096594492487; magda_turkey@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: catract and refractive surgery specialist

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

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 27, 2021
• Study Start: November 1, 2020
• Primary Completion: July 30, 2021
• Study Completion: October 30, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)