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Study on Visual Performance of a Monofocal Intraocular Lens

Sponsor
Carl Zeiss Meditec AG (Industry)
Overall Status
Completed
CT.gov ID
NCT04740788
Collaborator
(none)
44
Enrollment
1
Location
2.9
Actual Duration (Months)
15.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retrospective/Prospective Study on Visual Performance of a Monofocal Intraocular Lens (IOL). The objective is to compare best corrected distance visual acuity (CDVA) between 1-3-month and 12- month follow-up.

Condition or Disease Intervention/Treatment Phase
  • Device: Monofocal IOL

Study Design

Study Type:
Observational
Actual Enrollment :
44 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Multicentric Retrospective/Prospective Study on Visual Performance of a Monofocal Intraocular Lens (IOL)
Actual Study Start Date :
Feb 19, 2021
Actual Primary Completion Date :
May 18, 2021
Actual Study Completion Date :
May 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Monofocal IOL

Patients already implanted with a monofocal IOL

Device: Monofocal IOL
Patients are already implanted with a monofocal lens

Outcome Measures

Primary Outcome Measures

  1. Best corrected distance visual acuity (CDVA) [12 months]

    Comparison between 1-3-month and 12- month follow-up results.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age 18 years or older;

  • Patients with monolateral or bilateral (only one eye will be the study eye) monofocal IOL implantation after uncomplicated surgery in the period between May 2019 and November 2019, if the follow-up visit can be performed 10-18 months after surgery;

  • No visual acuity limiting pathologies;

  • Availability of 1-3-month postoperative data

  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures in case of a prospective 12-month visit;

  • Written informed consent for participation in the study and data protection.

Exclusion Criteria:

  • Difficulty for cooperation (distance from their home, general health conditions)

  • Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that would confound visual acuity measurements;

  • Subjects with surgical complications or secondary interventions (except for Nd:YAG capsulotomy) related to the cataract surgery of the monofocal IOL eye(s) or any other interventions in the post-operative eye including but not limited to glaucoma surgery, retinal surgery;

  • Visual field loss which has impact on visual acuity;

  • Use of systemic or ocular medication that might affect vision;

  • Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus;

  • Capsular or zonular abnormalities that have affected postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome);

  • Concurrent participation in another device investigation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Borkenstein & Borkenstein Graz Austria 8010

Sponsors and Collaborators

  • Carl Zeiss Meditec AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
NCT04740788
Other Study ID Numbers:
  • GPAS-SUR-020-02
First Posted:
Feb 5, 2021
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Aug 17, 2021