Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses

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

Clinical Phase

NA

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2018-06-26

Brief Summary

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Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation

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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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409M

CT ASPHINA 409M IOL

Group Type EXPERIMENTAL

CT ASPHINA 409

Intervention Type DEVICE

intraocular lens

Interventions

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CT ASPHINA 409

intraocular lens

Intervention Type DEVICE

Eligibility Criteria

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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
* Assured follow-up examinations
* Biometry measurement preferably compatible with the IOLMaster evaluation;
* IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
* Patients who had uncomplicated (no peroperative complication) aged-related cataract surgery in a healthy eye (beside clinically significant cataract)

Exclusion Criteria

* BCVA not available preoperatively or better than 0.3 logMAR pre-op
* 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 -

Eligible Sex

ALL

Accepts Healthy Volunteers

No