Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT05750251
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2023-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Upper Eyelid Surgeries on Corneal Characteristics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D001763', 'term': 'Blepharoptosis'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2023-02-06', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from best corrected visual acuity at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Assess best corrected visual acuity by qualified optometrists, with Landolt C chart-based examination Record as decimal visual acuity'}, {'measure': 'Change from intraocular pressure at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Measure intraocular pressure with tonometers in unit of mmHg'}, {'measure': 'Change from eyeball axial length at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Measure eyeball axial length with A-scan in unit of mm'}, {'measure': 'Change from slit lamp examination at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Assess local findings with a slit lamp by same and only ophthalmologist, Dr. YH Wei'}, {'measure': 'Change from margin to reflex distance (MRD) at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Measure margin to reflex distance with a ruler in unit of mm by same and only ophthalmologist, Dr. YH Wei MRD-1: from the corneal light reflex to the level of the center of the upper-eyelid margin MRD-2: from the corneal light reflex to the central portion of the lower eyelid'}, {'measure': 'Change from levator muscle function (LMF) at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Measure levator muscle function with a ruler in unit of mm by same and only ophthalmologist, Dr. YH Wei LMF: the distance the eyelid travel from downgaze to upgaze while the frontalis muscle is held inactive at the brow'}, {'measure': 'Change from lagophthalmos at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Measure lagophthalmos with a ruler in unit of mm by same and only ophthalmologist, Dr. YH Wei'}, {'measure': 'Change from basal tear volume at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': "Measure basal tear volume with Schirmer's test in unit of mm/5 minutes Schirmer's test: small paper strip with rulers printed is placed over the temporal one-third of the lower lid margin and inserted inside the inferior conjunctival fornices under local infiltrating anesthesia. The strips are removed after 5 minutes and the amount of tears produced in that time is measured by reading off of the length of wetting in millimeters."}, {'measure': 'Change from ocular surface disease index (OSDI) at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Interview participants with OSDI questionnaire to assesses dry eye symptoms and the effects on vision-related function by same and only ophthalmologist, Dr. YH Wei'}, {'measure': 'Change from tear break up time at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Measure tear break up time with Oculus Keratograph 5M (OCULUS, Wetzlar, Germany) in unit of sec'}, {'measure': 'Change from corneal biomechanical characteristics at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Measure corneal biomechanical characteristics with Oculus Corvis ST tonometer (OCULUS, Wetzlar, Germany)'}, {'measure': 'Change from corneal topography at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Measure corneal topography with Tomey TMS topographer (TOMEY, Nuremberg, Germany) and record as topography map.'}, {'measure': 'Change from higher-order corneal aberrations at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Measure higher-order corneal aberrations with Tracey iTrace wavefront aberrometer and corneal topography (TRACEY, Texas, USA), using beam of light projected into the eyes. The wavefront of the reflected light is captured by the machine and collected the distortion and aberration of the cornea.'}, {'measure': 'Change from corneal epithelial thickness at 3 months after the surgery', 'timeFrame': 'Baseline, Month 1, Month 3', 'description': 'Measure corneal epithelial thickness with anterior segment optical coherence tomography in unit of micrometer (Visionix USA, Illinois, USA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blepharoplasty'], 'conditions': ['Eyelid Diseases', 'Ptosis, Eyelid']}, 'referencesModule': {'references': [{'pmid': '35196840', 'type': 'BACKGROUND', 'citation': 'Aksu Ceylan N, Yeniad B. Effects of Upper Eyelid Surgery on the Ocular Surface and Corneal Topography. Turk J Ophthalmol. 2022 Feb 23;52(1):50-56. doi: 10.4274/tjo.galenos.2021.63255.'}, {'pmid': '26751993', 'type': 'BACKGROUND', 'citation': "Savino G, Battendieri R, Riso M, Traina S, Poscia A, D'Amico G, Caporossi A. Corneal Topographic Changes After Eyelid Ptosis Surgery. Cornea. 2016 Apr;35(4):501-5. doi: 10.1097/ICO.0000000000000729."}, {'pmid': '30130332', 'type': 'BACKGROUND', 'citation': "Ozturk Karabulut G, Fazil K. Corneal Topographical Changes After Muller's Muscle-conjunctival Resection Surgery. Ophthalmic Plast Reconstr Surg. 2019 Mar/Apr;35(2):177-181. doi: 10.1097/IOP.0000000000001203."}, {'pmid': '32135543', 'type': 'BACKGROUND', 'citation': 'Zloto O, Matani A, Sagiv O, Prat D, Ben Artsi E, Leshno A, Priel A, Ben Simon GJ. Changes in Refraction and Visual Acuity after Upper Eyelid Blepharoplasty versus Posterior Approach Ptosis Procedures. Ophthalmic Res. 2020;63(6):588-592. doi: 10.1159/000506951. Epub 2020 Mar 5.'}, {'pmid': '31203659', 'type': 'BACKGROUND', 'citation': 'Altin Ekin M, Karadeniz Ugurlu S. Prospective analysis of visual function changes in patients with dermatochalasis after upper eyelid blepharoplasty. Eur J Ophthalmol. 2020 Sep;30(5):978-984. doi: 10.1177/1120672119857501. Epub 2019 Jun 17.'}, {'pmid': '33229668', 'type': 'BACKGROUND', 'citation': 'Bhattacharjee K, Misra D, Singh M, Deori N. Long-term changes in contrast-sensitivity, corneal topography and higher-order aberrations after upper eyelid blepharoplasty: A prospective interventional study. Indian J Ophthalmol. 2020 Dec;68(12):2906-2910. doi: 10.4103/ijo.IJO_907_20.'}, {'pmid': '31558826', 'type': 'BACKGROUND', 'citation': 'Li X, Liu C, Mao Z, Liang X, Li Z, Liu X, Gong R, Huang D. Effect of congenital blepharoptosis on corneal biomechanical properties and changes after ptosis surgery. Eye (Lond). 2020 Jun;34(6):1055-1062. doi: 10.1038/s41433-019-0586-9. Epub 2019 Sep 26.'}, {'pmid': '34478004', 'type': 'BACKGROUND', 'citation': 'Sommer F, Untch E, Spoerl E, Herber R, Pillunat LE, Terai N. Effect of upper eyelid blepharoplasty on corneal biomechanical, topographic and tomographic parameters 4 weeks after surgery. Int Ophthalmol. 2022 Jan;42(1):113-121. doi: 10.1007/s10792-021-02006-6. Epub 2021 Sep 3.'}, {'pmid': '28025794', 'type': 'BACKGROUND', 'citation': 'Dogan AS, Acar M, Kosker M, Arslan N, Gurdal C. Alterations in corneal epithelial thickness in patients with congenital myogenic eyelid ptosis. Int Ophthalmol. 2018 Feb;38(1):53-57. doi: 10.1007/s10792-016-0419-9. Epub 2016 Dec 26.'}, {'pmid': '33881809', 'type': 'BACKGROUND', 'citation': 'Yamamoto R, Ono T, Toyono T, Shirakawa R, Noda M, Yoshida J, Miyai T. Assessment of Long-Term Anterior and Posterior Topographic Changes in the Cornea After Ptosis Surgery Using Fourier Harmonic Analysis. Cornea. 2021 Apr;40(4):440-444. doi: 10.1097/ICO.0000000000002429.'}, {'pmid': '34441401', 'type': 'BACKGROUND', 'citation': 'Kanclerz P, Khoramnia R, Wang X. Current Developments in Corneal Topography and Tomography. Diagnostics (Basel). 2021 Aug 13;11(8):1466. doi: 10.3390/diagnostics11081466.'}, {'pmid': '24326332', 'type': 'BACKGROUND', 'citation': 'Grubbs JR Jr, Tolleson-Rinehart S, Huynh K, Davis RM. A review of quality of life measures in dry eye questionnaires. Cornea. 2014 Feb;33(2):215-8. doi: 10.1097/ICO.0000000000000038.'}, {'pmid': '10815152', 'type': 'BACKGROUND', 'citation': 'Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.'}, {'pmid': '29635068', 'type': 'BACKGROUND', 'citation': 'Ang M, Baskaran M, Werkmeister RM, Chua J, Schmidl D, Aranha Dos Santos V, Garhofer G, Mehta JS, Schmetterer L. Anterior segment optical coherence tomography. Prog Retin Eye Res. 2018 Sep;66:132-156. doi: 10.1016/j.preteyeres.2018.04.002. Epub 2018 Apr 7.'}]}, 'descriptionModule': {'briefSummary': "The goal of this prospective observational study is to learn about the impact of conventional eyelid correction surgery on the eye's health and function in ptosis and eyelid retraction patient. The main questions it aims to answer are: •\n\n1. Changes in corneal topography, higher-order corneal aberrations, corneal biomechanical characteristics, and corneal epithelial thickness before and after the surgery\n2. Influence of corneal refraction examinations , vision change, and tear film function after the surgery\n\nFifty participants will undergo conventional eyelid correction surgery by the same ophthalmologist (YH Wei) and non-invasive examinations before and after the surgery. The patient will be separate to 2 groups, including 30 with correction for ptosis and 20 with correction for eyelid retraction. The research will collect information of the operated eye and fellow eye, and the data will be compared between operated and fellow eye and with the other group.", 'detailedDescription': 'The position of the upper eyelid affects the health and function of the eye. Ptosis can obstruct the vision, and eyelid retraction can result in the loss of proper protection of the ocular surface. Through conventional upper eyelid correction surgery, the height of the upper eyelid can be adjusted to a proper position. However, after upper eyelid surgery, the pressure of the upper eyelid on the corneal surface may change, affecting corneal topography, higher-order corneal aberrations, corneal biomechanical characteristics, and corneal epithelial thickness. These changes may affect postoperative vision and visual quality. The impact of upper eyelid surgery on corneal refraction and corneal biomechanical characteristics remains inconclusive in current studies, and the impact on corneal epithelial thickness is even less investigated. This is a prospective observational study, expecting to enroll 50 patients who have undergone upper eyelid surgery, including 30 for ptosis correction and 20 for eyelid retraction correction. Non-invasive examinations will be used to assess changes in corneal topography, higher-order corneal aberrations, corneal biomechanical characteristics, and corneal epithelial thickness before and after the surgery to understand the impact of upper eyelid surgery on the ocular surface and the possible mechanism or influencing factors of postoperative vision changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants from 20-year-old to 80-year old who need eyelid correction surgery, Group 1 : Ptosis patient with marginal reflex distance 1 (MRD1) ≦ 2-2.5 mm and levator muscle fundction (LMF) ≧ 8 mm; Group 2 : Eyelid retraction patient with upper scleral show. The population excluded patients with pregnancy, previous corneal surgery, corneal scar, pterygium, keratoconus, significant ocular surface disease, or wearing rigid contact lens.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup 1:\n\n* marginal reflex distance 1 (MRD1) ≦ 2-2.5 mm\n* levator muscle function (LMF) ≧ 8 mm\n\nGroup 2:\n\n* with upper scleral show\n\nExclusion Criteria:\n\n* pregnancy\n* previous corneal surgery\n* with corneal scar\n* pterygium\n* keratoconus\n* significant ocular surface disease\n* wearing rigid contact lens'}, 'identificationModule': {'nctId': 'NCT05750251', 'briefTitle': 'Effect of Upper Eyelid Surgeries on Corneal Characteristics', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effect of Upper Eyelid Surgeries on Corneal Topography, Corneal High-order Aberration, Corneal Biomechanical Properties, and Corneal Epithelial Thickness', 'orgStudyIdInfo': {'id': '202211048RINA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ptosis patient', 'description': "Undergo conventional ptosis correction surgery, including levator muscle resection surgery and Müller's muscle-conjuctival resection surgery", 'interventionNames': ['Procedure: levator muscle resection surgery', "Procedure: Müller's muscle-conjuctival resection surgery"]}, {'label': 'Eyelid retraction patient', 'description': 'Undergo conventional ptosis correction surgery, including full-thickness anterior blepharotomy surgery', 'interventionNames': ['Procedure: full-thickness anterior blepharotomy surgery']}], 'interventions': [{'name': 'levator muscle resection surgery', 'type': 'PROCEDURE', 'description': 'conventional ptosis surgery', 'armGroupLabels': ['Ptosis patient']}, {'name': "Müller's muscle-conjuctival resection surgery", 'type': 'PROCEDURE', 'description': 'conventional ptosis surgery', 'armGroupLabels': ['Ptosis patient']}, {'name': 'full-thickness anterior blepharotomy surgery', 'type': 'PROCEDURE', 'description': 'conventional eyelid retraction surgery', 'armGroupLabels': ['Eyelid retraction patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yi-Hsuan Wei, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital, Department of Ophthalmology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}