Effect of Upper Eyelid Surgeries on Corneal Characteristics
NCT ID: NCT05750251
Last Updated: 2024-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
13 participants
OBSERVATIONAL
2023-02-06
2023-07-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. Changes in corneal topography, higher-order corneal aberrations, corneal biomechanical characteristics, and corneal epithelial thickness before and after the surgery
2. Influence of corneal refraction examinations , vision change, and tear film function after the surgery
Fifty 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison Between Bare Scleral Technique and Conjunctival Auto-graft on Corneal Topography After Pterygium Surgery
NCT05812508
Corneal Topographic Changes After Pterygium Surgery
NCT05026307
Levator Muscle Reaction for Unilateral Congenital Ptosis Repair as Compared to Levator Plication
NCT05895695
Corneal Endothelium in Diabetics Undergoing Phacoemulsification
NCT05522842
Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries
NCT01075347
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ptosis patient
Undergo conventional ptosis correction surgery, including levator muscle resection surgery and Müller's muscle-conjuctival resection surgery
levator muscle resection surgery
conventional ptosis surgery
Müller's muscle-conjuctival resection surgery
conventional ptosis surgery
Eyelid retraction patient
Undergo conventional ptosis correction surgery, including full-thickness anterior blepharotomy surgery
full-thickness anterior blepharotomy surgery
conventional eyelid retraction surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
levator muscle resection surgery
conventional ptosis surgery
Müller's muscle-conjuctival resection surgery
conventional ptosis surgery
full-thickness anterior blepharotomy surgery
conventional eyelid retraction surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* marginal reflex distance 1 (MRD1) ≦ 2-2.5 mm
* levator muscle function (LMF) ≧ 8 mm
Group 2:
* with upper scleral show
Exclusion Criteria
* previous corneal surgery
* with corneal scar
* pterygium
* keratoconus
* significant ocular surface disease
* wearing rigid contact lens
20 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Taiwan University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yi-Hsuan Wei, PhD
Role: STUDY_CHAIR
National Taiwan University Hospital, Department of Ophthalmology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Taiwan University Hospital
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202211048RINA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.