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

March 8, 2021 updated by: Rupert Menapace, Medical University of Vienna

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of FBGC (foreign body giant cells) (slitlamp examination)
Time Frame: 5 months
The number of foreign body giant cells on the IOLs will be assessed.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Monocytes (slitlamp examination)
Time Frame: 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
5 months
PCO Score (slitlamp examination)
Time Frame: 5 months
Incidence and development of posterior capsular opacification will be subjectively graded: 0-10 (0= no PCO, 10= maximum PCO)
5 months
Grade of Anterior Fibrosis (slitlamp examination)
Time Frame: 5 months
Grade of anterior fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
5 months
Anterior chamber reaction (slitlamp examination)
Time Frame: 5 months
Incidence of cells and tyndall in the anterior chamber (ratet as - to +++ respectively)
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2021

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 14, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2060/2019 (Other Identifier: Medical University of Vienna - Ethic Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age Related Cataracts

Clinical Trials on Vivinex XY1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe