Study on Visual Performance of a Monofocal Intraocular Lens

Cataract Senile Clinical Trial

Official title:

Multicentric Retrospective/Prospective Study on Visual Performance of a Monofocal Intraocular Lens (IOL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740788
• Other study ID #: GPAS-SUR-020-02
• Status: Completed
• Start date: February 19, 2021
• Est. completion date: May 18, 2021

Study information

• Verified date: August 2021
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 18, 2021
• Est. primary completion date: May 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Intervention

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

Locations

Country	Name	City	State
Austria	Borkenstein & Borkenstein	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected distance visual acuity (CDVA)	Comparison between 1-3-month and 12- month follow-up results.	12 months