Influence of Pupillary Behavior During Eye Surgery on Morphological and Functional Outcome

December 6, 2023 updated by: Yosuf El-Shabrawi, Klinikum Klagenfurt am Wörthersee
Pupillary movement during eye surgery can be a challenge for eye surgeons. Despite the risk of intraocular lens damage and malpositioning due to mechanical manipulation1, iris manipulation may lead to a significant elevation of cytokines in the aqueous humor and an increase of postoperative inflammation2, 3. Iris damage is also known to lead to an increase of prostaglandin production which will not only lead to an increase of inflammation but also has an impact on intraoperative miosis4. This leads to the assumption that postoperative inflammation can be related to intraoperative pupillary movements due to the same leading cause of an increase of inflammatory mediators. Tracking intraoperative pupillary movements might therefore be a helpful tool for the prediction of postoperative PCME and could have an impact on therapeutic decisions after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

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

Study Locations

  • Austria
    • Carinthia
      • Klagenfurt, Carinthia, Austria, 9020

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients receiving surgery and that want to participate in the study.

Description

Inclusion Criteria:

  • presence of significant cataract,
  • written consent.
  • presence of other ocular conditions requiring surgery such as: degenerative corneal disease, retinal conditions (i.e. macular pucker)

Exclusion Criteria:

- reasons for poor video quality (such as poor red reflex due to abnormal anatomy)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pupillary movement
Time Frame: during surgery
Analyzing the extend of pupil movement during cataract surgery
during surgery
IOL rotation
Time Frame: Video taken immediately postoperative and 2-4 weeks postoperative
The rotation of the IOL directly after surgery and a 2-4 weeks postoperative when the second eye is operated.
Video taken immediately postoperative and 2-4 weeks postoperative
retinal thickness
Time Frame: at baseline and 2-4 weeks postoperative
OCT Scan to measure retinal thickness at baseline and 2-4 weeks after surgery
at baseline and 2-4 weeks postoperative

Collaborators and Investigators

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

Sponsor

Klinikum Klagenfurt am Wörthersee

Collaborators

University of Klagenfurt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 9, 2017

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

November 25, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Estimated)

December 7, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A 28/17

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.

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