CataractNCT06160960
Influence of Pupillary Behavior During Eye Surgery on Morphological and Functional Outcome
An observational study of Cataract and Corneal Disease, run by Klinikum Klagenfurt am Wörthersee at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract, Corneal Disease, Vitreous Disorder
- What is being tested?
- OCT Scan, Video of pupil movement, video of toric lens
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- 9 Oct 2017to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients receiving surgery and that want to participate in the study.
Who may be able to join
- presence of significant cataract,
- written consent.
- presence of other ocular conditions requiring surgery such as: degenerative corneal disease, retinal conditions (i.e. macular pucker)
Who cannot join
- reasons for poor video quality (such as poor red reflex due to abnormal anatomy)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
KlinikumKlagenfurt
Klagenfurt, Carinthia, 9020
Yosuf El-Shabrawi, MD, +43 463 538-32403, yosuf.El-Shabrawi@kabeg.at
About this study
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.
- Conditions
- Cataract, Corneal Disease, Vitreous Disorder
- Being tested
- OCT Scan, Video of pupil movement, video of toric lens
- Keywords
- Cataract, refractive surgery, vitrectomy
- Medical subject headings
- Cataract, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
pupillary movement
Analyzing the extend of pupil movement during cataract surgery
Measured: during surgery
IOL rotation
The rotation of the IOL directly after surgery and a 2-4 weeks postoperative when the second eye is operated.
Measured: 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
Measured: at baseline and 2-4 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start9 Oct 2017
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Klagenfurt am Wörthersee
- Sponsor type
- University, hospital or other
- Collaborators
- University of Klagenfurt
- Responsible party
- Principal investigator, Yosuf El-Shabrawi, Klinikum Klagenfurt am Wörthersee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160960
- Sponsor's protocol ID
- A 28/17
- Status last verified
- Dec 2023
- First submitted
- 25 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35035046Aketa 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.
PubMed 28475702Williams 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.
PubMed 34012881AMBACHE 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.
PubMed 14289827
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pupillary Behavior During Eye Surgery on Morphological and Functional Outcome
- ClinicalTrials.gov ID
- NCT06160960
- Acronym / sponsor ID
- A 28/17
- Conditions
- Cataract, Corneal Disease, Vitreous Disorder
- Keywords
- Cataract, refractive surgery, vitrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Klinikum Klagenfurt am WörtherseeUniversity, hospital or other
- Collaborators
- University of Klagenfurt
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving surgery and that want to participate in the study.
Key inclusion criteria (3 listed)
- presence of significant cataract,
- written consent.
- presence of other ocular conditions requiring surgery such as: degenerative corneal disease, retinal conditions (i.e. macular pucker)
Key exclusion criteria (1 listed)
- reasons for poor video quality (such as poor red reflex due to abnormal anatomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT Scan, Video of pupil movement, video of toric lensA picture of the central macular area is taken, video of pupil movment, video of toric lens rotation. | Other | – |
Primary outcome
pupillary movement
Time frame: during surgery
Analyzing the extend of pupil movement during cataract surgery
IOL rotation
Time frame: Video taken immediately postoperative and 2-4 weeks postoperative
The rotation of the IOL directly after surgery and a 2-4 weeks postoperative when the second eye is operated.
retinal thickness
Time frame: at baseline and 2-4 weeks postoperative
OCT Scan to measure retinal thickness at baseline and 2-4 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Results publication: PubMed 35035046Singh 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.
- Results publication: PubMed 28475702Aketa 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.
- Results publication: PubMed 34012881Williams 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.
- Results publication: PubMed 14289827AMBACHE 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Corneal Disease, run by Klinikum Klagenfurt am Wörthersee at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yosuf El-Shabrawi, MD (+43 463 538-32403, yosuf.El-Shabrawi@kabeg.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pupillary movement (time frame: during surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06160960, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.