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

V

Vienna Institute for Research in Ocular Surgery

Status

Completed

Conditions

Cataract Surgery, Single-piece IOL, Microincisional IOL

Treatments

Procedure: Cataract surgery with implantation of a single-piece microincisional IOL

Study type

Interventional

Funder types

Other

Identifiers

NCT07167589
Viros_HOYA

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

21 to 105 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

42 participants in 1 patient group

HOYA acrylic single-piece IOL (HOYA AF-1 NY-60)
Other group
Treatment:
Procedure: Cataract surgery with implantation of a single-piece microincisional IOL

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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