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

NCT ID: NCT06160960

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-09

Study Completion Date

2024-10-01

Brief Summary

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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

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Conditions

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Cataract Corneal Disease Vitreous Disorder

Keywords

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Cataract refractive surgery vitrectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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OCT Scan, Video of pupil movement, video of toric lens

A picture of the central macular area is taken, video of pupil movment, video of toric lens rotation.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Klagenfurt

OTHER

Sponsor Role collaborator

Klinikum Klagenfurt am Wörthersee

OTHER

Sponsor Role lead

Responsible Party

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Yosuf El-Shabrawi

Prim. Univ. Prof. Dr. Yosuf El-Shabrawi

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KlinikumKlagenfurt

Klagenfurt, Carinthia, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Yosuf El-Shabrawi, MD

Role: CONTACT

Phone: +43 463 538-32403

Email: [email protected]

Facility Contacts

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Yosuf El-Shabrawi, MD

Role: primary

References

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Singh A, Kapoor G, Baranwal VK, Kalra N. Rotational stability of Toric intraocular lenses. Med J Armed Forces India. 2022 Jan;78(1):68-73. doi: 10.1016/j.mjafi.2020.03.014. Epub 2020 Jul 9.

Reference Type RESULT
PMID: 35035046 (View on PubMed)

Aketa N, Yamaguchi T, Suzuki T, Higa K, Yagi-Yaguchi Y, Satake Y, Tsubota K, Shimazaki J. Iris Damage Is Associated With Elevated Cytokine Levels in Aqueous Humor. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO42-BIO51. doi: 10.1167/iovs.17-21421.

Reference Type RESULT
PMID: 28475702 (View on PubMed)

Williams ER, Patnaik JL, Miller DC, Lynch AM, Davidson RS, Kahook MY, Seibold LK. Iris manipulation during phacoemulsification: intraoperative and postoperative complications. Int J Ophthalmol. 2021 May 18;14(5):676-683. doi: 10.18240/ijo.2021.05.06. eCollection 2021.

Reference Type RESULT
PMID: 34012881 (View on PubMed)

AMBACHE N, KAVANAGH L, WHITING J. EFFECT OF MECHANICAL STIMULATION ON RABBITS' EYES: RELEASE OF ACTIVE SUBSTANCE IN ANTERIOR CHAMBER PERFUSATES. J Physiol. 1965 Feb;176(3):378-408. doi: 10.1113/jphysiol.1965.sp007557. No abstract available.

Reference Type RESULT
PMID: 14289827 (View on PubMed)

Other Identifiers

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A 28/17

Identifier Type: -

Identifier Source: org_study_id