NCT06160960

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2017

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

7 years

First QC Date

November 25, 2023

Last Update Submit

December 6, 2023

Conditions

CataractCorneal DiseaseVitreous Disorder

Keywords

Cataractrefractive surgeryvitrectomy

Outcome Measures

Primary Outcomes (3)

  • pupillary movement

    Analyzing the extend of pupil movement during cataract surgery

    during surgery

  • IOL rotation

    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

    OCT Scan to measure retinal thickness at baseline and 2-4 weeks after surgery

    at baseline and 2-4 weeks postoperative

Interventions

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

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

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KlinikumKlagenfurt

Klagenfurt, Carinthia, 9020, Austria

RECRUITING

Related Publications (4)

  • 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.

    PMID: 35035046RESULT

  • 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.

    PMID: 28475702RESULT

  • 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.

    PMID: 34012881RESULT

  • 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.

    PMID: 14289827RESULT

MeSH Terms

Conditions

CataractCorneal Diseases

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Central Study Contacts

Yosuf El-Shabrawi, MD

CONTACT

+43 463 538-32403yosuf.El-Shabrawi@kabeg.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prim. Univ. Prof. Dr. Yosuf El-Shabrawi

Study Record Dates

First Submitted

November 25, 2023

First Posted

December 7, 2023

Study Start

October 9, 2017

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

December 7, 2023

Record last verified: 2023-12

Locations

AU(1)