Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT06160960
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Pupillary Behavior During Eye Surgery on Morphological and Functional Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2023-11-25', 'studyFirstSubmitQcDate': '2023-12-06', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pupillary movement', 'timeFrame': 'during surgery', 'description': 'Analyzing the extend of pupil movement during cataract surgery'}, {'measure': 'IOL rotation', 'timeFrame': 'Video taken immediately postoperative and 2-4 weeks postoperative', 'description': 'The rotation of the IOL directly after surgery and a 2-4 weeks postoperative when the second eye is operated.'}, {'measure': 'retinal thickness', 'timeFrame': 'at baseline and 2-4 weeks postoperative', 'description': 'OCT Scan to measure retinal thickness at baseline and 2-4 weeks after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cataract', 'refractive surgery', 'vitrectomy'], 'conditions': ['Cataract', 'Corneal Disease', 'Vitreous Disorder']}, 'referencesModule': {'references': [{'pmid': '35035046', 'type': 'RESULT', '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.'}, {'pmid': '28475702', 'type': 'RESULT', '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.'}, {'pmid': '34012881', 'type': 'RESULT', '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.'}, {'pmid': '14289827', 'type': 'RESULT', '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."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients receiving surgery and that want to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of significant cataract,\n* written consent.\n* presence of other ocular conditions requiring surgery such as: degenerative corneal disease, retinal conditions (i.e. macular pucker)\n\nExclusion Criteria:\n\n\\- reasons for poor video quality (such as poor red reflex due to abnormal anatomy)'}, 'identificationModule': {'nctId': 'NCT06160960', 'briefTitle': 'Influence of Pupillary Behavior During Eye Surgery on Morphological and Functional Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum Klagenfurt am Wörthersee'}, 'officialTitle': 'Influence of Pupillary Behavior During Eye Surgery on Morphological and Functional Outcome', 'orgStudyIdInfo': {'id': 'A 28/17'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OCT Scan, Video of pupil movement, video of toric lens', 'type': 'OTHER', 'description': 'A picture of the central macular area is taken, video of pupil movment, video of toric lens rotation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9020', 'city': 'Klagenfurt', 'state': 'Carinthia', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Yosuf El-Shabrawi, MD', 'role': 'CONTACT', 'email': 'yosuf.El-Shabrawi@kabeg.at', 'phone': '+43 463 538-32403'}], 'facility': 'KlinikumKlagenfurt', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}], 'centralContacts': [{'name': 'Yosuf El-Shabrawi, MD', 'role': 'CONTACT', 'email': 'yosuf.El-Shabrawi@kabeg.at', 'phone': '+43 463 538-32403'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinikum Klagenfurt am Wörthersee', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Klagenfurt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prim. Univ. Prof. Dr. Yosuf El-Shabrawi', 'investigatorFullName': 'Yosuf El-Shabrawi', 'investigatorAffiliation': 'Klinikum Klagenfurt am Wörthersee'}}}}