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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06160960
• Other study ID #: A 28/17
• Status: Recruiting
• Start date: October 9, 2017
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2023
• Source: Klinikum Klagenfurt am Wörthersee
• Contact: Yosuf El-Shabrawi, MD
• Phone: +43 463 538-32403
• Email: yosuf.El-Shabrawi[@]kabeg.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cataract
• Corneal Disease
• Corneal Diseases
• Vitreous Disorder

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Austria	KlinikumKlagenfurt	Klagenfurt	Carinthia

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Klagenfurt am Wörthersee	University of Klagenfurt

Country where clinical trial is conducted

Austria, 

References & Publications (4)

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. — View 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. — View 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. — View 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. eCol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pupillary movement	Analyzing the extend of pupil movement during cataract surgery	during surgery
Primary	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
Primary	retinal thickness	OCT Scan to measure retinal thickness at baseline and 2-4 weeks after surgery	at baseline and 2-4 weeks postoperative