Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904887
• Other study ID #: 02282021065725
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: May 2021
• Source: Dar Al Shifa Hospital
• Contact: Magda Torky
• Phone: 0096594492487
• Email: magda_turkey[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

insertion of new intraocular lens enhanced for intermediate vision

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Presbyopia

Intervention

Procedure:
• phacoemulsification
phacoemulsification with implantation of EYEHANCE IOL

Locations

Country	Name	City	State
Kuwait	Daralshifa hospital	Kuwait

Sponsors (1)

Lead Sponsor	Collaborator
Dar Al Shifa Hospital

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	defocus curve	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