Clinical trial NCT06160960: Influence of Pupillary Behavior During Eye Surgery on Morphological and Functional Outcome
Official title: Influence of Pupillary Behavior During Eye Surgery on Morphological and Functional Outcome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Corneal Disease
Vitreous Disorder
Keywords: Cataract
refractive surgery
vitrectomy
Lead sponsor: Klinikum Klagenfurt am Wörthersee
Sponsor class: OTHER
Collaborators: name: University of Klagenfurt
First posted: 2023-12-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving surgery and that want to participate in the study.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: pupillary movement
timeFrame: during surgery
measure: IOL rotation
timeFrame: Video taken immediately postoperative and 2-4 weeks postoperative
measure: retinal thickness
timeFrame: at baseline and 2-4 weeks postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: KlinikumKlagenfurt
state: Carinthia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.