Study on Visual Performance of a Monofocal Intraocular Lens

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04740788

Enrollment

Registered

2021-02-05

Start date

2021-02-19

Completion date

2021-05-18

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Senile

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.

Interventions

DEVICEMonofocal IOL

Patients are already implanted with a monofocal lens

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026