Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models

Sponsor
Medical University of Vienna (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04230629
Collaborator
(none)
50
2
15.5

Study Details

Study Description

Brief Summary

On the day of surgery, the the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH.

A complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) postoperatively.

Condition or Disease Intervention/Treatment Phase
  • Device: Vivinex XY1
  • Device: Vivinex XY1A
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination.The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models
Anticipated Study Start Date :
Mar 15, 2021
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Vivinex XY1

Implantation of an intraocular lens Hoya Vivinex XY1

Device: Vivinex XY1
Implantation of an intraocular lens Hoya Vivinex XY1

Active Comparator: Vivinex XY1A

Implantation of an intraocular lens Hoya Vivinex XY1A

Device: Vivinex XY1A
Implantation of an intraocular lens Hoya Vivinex XY1A

Outcome Measures

Primary Outcome Measures

  1. Number of FBGC (foreign body giant cells) (slitlamp examination) [5 months]

    The number of foreign body giant cells on the IOLs will be assessed.

Secondary Outcome Measures

  1. Incidence of Monocytes (slitlamp examination) [5 months]

    The number of monocytes on the IOLs will be assessed. The following classification will be used: + = fewer than 10 cells/mm2; ++ = 10 to 25 cells/mm2; +++ = more than 25 cells/mm2

  2. PCO Score (slitlamp examination) [5 months]

    Incidence and development of posterior capsular opacification will be subjectively graded: 0-10 (0= no PCO, 10= maximum PCO)

  3. Grade of Anterior Fibrosis (slitlamp examination) [5 months]

    Grade of anterior fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)

  4. Anterior chamber reaction (slitlamp examination) [5 months]

    Incidence of cells and tyndall in the anterior chamber (ratet as - to +++ respectively)

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned

  • Age 40 and older

  • Astigmatism of at least 0.75Diopters in one eye

  • Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:
  • Diabetes mellitus

  • Pseudoexfoliation syndrome

  • Systemical anticoagulation

  • Antiphlogistic therapy

  • Antiglaucomatosa

  • Uncontrolled systemic or ocular disease

  • Preceding ocular surgery or trauma

  • Intraoperative complications

  • Pregnancy/Nursing

  • Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rupert Menapace, Clinical Professor, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04230629
Other Study ID Numbers:
  • 2060/2019
First Posted:
Jan 18, 2020
Last Update Posted:
Mar 9, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2021