Capsule Bag Performance of a Novel Single-piece Acrylic IOL HOYA AF-1 NY-60

NCT ID: NCT07167589

Last Updated: 2025-09-23

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-01

Study Completion Date

2013-12-01

Brief Summary

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During the past decades, cataract surgery underwent tremendous change and modernisation resulting in today's small incision, phacoemulsification surgery and a safe technique with a short rehabilitation time for the patient.

In this study the capsule performance and stability of a new one-piece microincisional hydrophobic acrylic IOL (HOYA AF-1 NY-60) should be assessed in subgroups of normal, short and long eyes. The IOL has a sharp optic edge design to inhibit PCO formation. Hypothesis: The novel haptic design is supposed to avoid tension folds in capsule bag, allow for a longer contact length of haptic with capsule equator, ensure rotational stability as well as good centration of the optic.

Detailed Description

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Conditions

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Cataract Surgery, Single-piece IOL, Microincisional IOL

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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HOYA acrylic single-piece IOL (HOYA AF-1 NY-60)

Group Type OTHER

Cataract surgery with implantation of a single-piece microincisional IOL

Intervention Type PROCEDURE

Interventions

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Cataract surgery with implantation of a single-piece microincisional IOL

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age-related cataract
* Age 21 and older
* Visual Acuity \> 0.05
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria

* Relevant other ophthalmic diseases especially those that may compromise capsule bag integrity or zonule stability (such as pseudoexfoliation syndrome, Marfan's syndrome, etc.)
* Preceding ocular surgery or trauma
* In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Minimum Eligible Age

21 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vienna Institute for Research in Ocular Surgery

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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Viros_HOYA

Identifier Type: -

Identifier Source: org_study_id

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