Compare Visual Outcomes Using a New Diagnostic Device

Terminated

• Conditions: Presbyopia

• Registration Number: NCT04037631
• Lead Sponsor: Carl Zeiss Meditec AG

Brief Summary

Evaluation of preoperative corrected distance visual acuity (CDVA) obtained with VirtIOL device compared to postoperative CDVA.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-20
• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-30
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent

• Patients of any gender, aged 18 years to open age

• Assured follow-up examinations

• Healthy eyes without clinically significant age-related cataract

Exclusion Criteria

• Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
• Patients whose freedom is impaired by administrative or legal order
• Concurrent participation in another drug or device investigation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corrected distance visual acuity (CDVA)	3 months after surgery	Evaluation of CDVA obtained with diagnostic device

Trial Locations

Locations (1)

Internationale Innovative Ophthalmologie; 🇩🇪 Düsseldorf, Germany