Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision

Sponsor

Dar Al Shifa Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04904887

Collaborator

(none)

Enrollment

Location

Arm

11.9

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Procedure: phacoemulsification	N/A

Detailed Description

insertion of new intraocular lens enhanced for intermediate vision

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Jul 30, 2021

Anticipated Study Completion Date :

Oct 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Daralshifa hospital	Kuwait		Kuwait

Sponsors and Collaborators

Dar Al Shifa Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

magda torky, catract and refractive surgery specialist, Dar Al Shifa Hospital

ClinicalTrials.gov Identifier:

NCT04904887

Other Study ID Numbers:

02282021065725

First Posted:

May 27, 2021

Last Update Posted:

May 27, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Presbyopia

Study Results

No Results Posted as of May 27, 2021