NCT06160960|Unknown
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Sponsor study identifier
observational
500
1 country
1
Study Start
October 9, 2017
Actual (reported)Primary Completion
October 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 9, 2017
Actual (reported)November 25, 2023
Actual (reported)December 7, 2023
Actual (reported)October 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
A picture of the central macular area is taken, video of pupil movment, video of toric lens rotation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients receiving surgery and that want to participate in the study.
KlinikumKlagenfurt
Klagenfurt, Carinthia, 9020, Austria
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.
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.
First Submitted
November 25, 2023
First Posted
December 7, 2023
Study Start
October 9, 2017
Actual (reported)Primary Completion
October 1, 2024
Estimated (date passed)Comparing an Intraoperative vs. a Standard Wavefront Device
Contact the study team to confirm eligibility.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 7, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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