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

Recruiting

• Conditions: Corneal Disease; Vitreous Disorder; Cataract

• Registration Number: NCT06160960
• Lead Sponsor: Klinikum Klagenfurt am Wörthersee

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-09
• Study First Submitted: 2023-11-25
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-06
• Last Update Submitted: 2023-12-06
• Study First Posted: 2023-12-07
• Last Update Posted: 2023-12-07
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pupillary movement	during surgery	Analyzing the extend of pupil movement during cataract surgery
IOL rotation	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.
retinal thickness	at baseline and 2-4 weeks postoperative	OCT Scan to measure retinal thickness at baseline and 2-4 weeks after surgery

Trial Locations

Locations (1)

KlinikumKlagenfurt; 🇦🇹 Klagenfurt, Carinthia, Austria