EDOF and Multifocal IOL Study

Age-related Cataract Clinical Trial

Official title:

Comparison of Visual Outcomes and Patient Satisfaction After Bilateral Implantation of EDOF and Multifcoal IOLs- a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05573529
• Other study ID #: 1163/2020
• Status: Completed
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: March 23, 2023

Study information

• Verified date: April 2024
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
• Age 50-90
• Visual potential in both eyes of 20/30 or better as determined by investigators estimation
• Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

• Preceding ocular surgery or trauma
• Relevant other ophthalmic diseases (such as retinal degenerations, etc.)
• Uncontrolled systemic or ocular disease

Related Conditions & MeSH terms

• Age-related Cataract
• Cataract

Intervention

Procedure:
• phacoemulsification and intraocular lens implantation
bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation

Device:
• intraocular lens implantation
intraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	distant corrected near visual acuity	Primary outcome measure will be monocular distant corrected near visual acuity (DCNVA) of each intraocular lens implanted. DCNVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.	6 months