Observational Prospective Clinical Investigation on Monofocal Toric Intraocular Lens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-24

Study Completion Date

2024-10-27

Brief Summary

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Evaluation, at least one-year long-term, of the clinical performance and safety of Mini Toric Ready Intraocular Lens (IOL), a monofocal toric intraocular lens.

Detailed Description

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Observational prospective clinical investigation based on the medical records of patients who undergone uncomplicated cataract surgery with implantation of Mini Toric Ready IOL and on a clinical visit after at least one year from the surgery. Eyes with corneal astigmatism ≥0.75 diopters were included. Postoperative evaluations included monocular or binocular uncorrected and corrected distance visual acuity; contrast sensitivity measured after at least one-year postoperatively.

Conditions

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Cataract Astigmatism

Keywords

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Cataract Astigmatism Monofocal IOL Toric IOL

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Mini Toric IOL

Adults (males and females) ≥18 years with cataract and pre-existing corneal astigmatism who have undergone monocular or binocular Mini Toric Ready implantation after cataract surgery in which the cataract lens was removed by phacoemulsification, with circular capsulorhexis, leaving the posterior capsule intact.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Eighteen years of age or older at the time of surgery and diagnosed with unilateral or bilateral cataracts;
* Preoperative total corneal astigmatism ≥0.75D;
* Unilateral or bilateral cataract removal by phacoemulsification;
* Clear intraocular media other than cataract;
* Willing and able to complete all required postoperative visits;
* Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects.

Exclusion Criteria

* Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days before the surgery.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gauss Clinic Bacau

Bacau, , Romania

Site Status

Immunoeye SRL

Sfântu Gheorghe, , Romania

Site Status

Countries

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Italy Romania

Other Identifiers

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055/SI

Identifier Type: -

Identifier Source: org_study_id