Effect of Upper Eyelid Surgeries on Corneal Characteristics

NCT05750251 | Completed

• 1 other identifier: 202211048RINA
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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: •

1. 1.Changes in corneal topography, higher-order corneal aberrations, corneal biomechanical characteristics, and corneal epithelial thickness before and after the surgery
2. 2.Influence of corneal refraction examinations , vision change, and tear film function after the surgery

Conditions

Eyelid Diseases; Ptosis, Eyelid

Keywords

Blepharoplasty

Outcome Measures

Primary Outcomes (14)

• Change from best corrected visual acuity at 3 months after the surgery

  Assess best corrected visual acuity by qualified optometrists, with Landolt C chart-based examination Record as decimal visual acuity

  Baseline, Month 1, Month 3

• Change from intraocular pressure at 3 months after the surgery

  Measure intraocular pressure with tonometers in unit of mmHg

  Baseline, Month 1, Month 3

• Change from eyeball axial length at 3 months after the surgery

  Measure eyeball axial length with A-scan in unit of mm

  Baseline, Month 1, Month 3

• Change from slit lamp examination at 3 months after the surgery

  Assess local findings with a slit lamp by same and only ophthalmologist, Dr. YH Wei

  Baseline, Month 1, Month 3

• Change from margin to reflex distance (MRD) at 3 months after the surgery

  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

  Baseline, Month 1, Month 3

• Change from levator muscle function (LMF) at 3 months after the surgery

  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

  Baseline, Month 1, Month 3

• Change from lagophthalmos at 3 months after the surgery

  Measure lagophthalmos with a ruler in unit of mm by same and only ophthalmologist, Dr. YH Wei

  Baseline, Month 1, Month 3

• Change from basal tear volume at 3 months after the surgery

  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.

  Baseline, Month 1, Month 3

• Change from ocular surface disease index (OSDI) at 3 months after the surgery

  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

  Baseline, Month 1, Month 3

• Change from tear break up time at 3 months after the surgery

  Measure tear break up time with Oculus Keratograph 5M (OCULUS, Wetzlar, Germany) in unit of sec

  Baseline, Month 1, Month 3

• Change from corneal biomechanical characteristics at 3 months after the surgery

  Measure corneal biomechanical characteristics with Oculus Corvis ST tonometer (OCULUS, Wetzlar, Germany)

  Baseline, Month 1, Month 3

• Change from corneal topography at 3 months after the surgery

  Measure corneal topography with Tomey TMS topographer (TOMEY, Nuremberg, Germany) and record as topography map.

  Baseline, Month 1, Month 3

• Change from higher-order corneal aberrations at 3 months after the surgery

  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.

  Baseline, Month 1, Month 3

• Change from corneal epithelial thickness at 3 months after the surgery

  Measure corneal epithelial thickness with anterior segment optical coherence tomography in unit of micrometer (Visionix USA, Illinois, USA)

  Baseline, Month 1, Month 3

Study Arms (2)

Ptosis patient

Undergo conventional ptosis correction surgery, including levator muscle resection surgery and Müller's muscle-conjuctival resection surgery

Procedure: levator muscle resection surgery; Procedure: Müller's muscle-conjuctival resection surgery

Eyelid retraction patient

Undergo conventional ptosis correction surgery, including full-thickness anterior blepharotomy surgery

Procedure: full-thickness anterior blepharotomy surgery

Interventions

levator muscle resection surgery PROCEDURE

conventional ptosis surgery

Ptosis patient

Müller's muscle-conjuctival resection surgery PROCEDURE

conventional ptosis surgery

Ptosis patient

full-thickness anterior blepharotomy surgery PROCEDURE

conventional eyelid retraction surgery

Eyelid retraction patient

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Group 1:
• marginal reflex distance 1 (MRD1) ≦ 2-2.5 mm
• levator muscle function (LMF) ≧ 8 mm
• Group 2:
• with upper scleral show

You may not qualify if:

• pregnancy
• previous corneal surgery
• with corneal scar
• pterygium
• keratoconus
• significant ocular surface disease
• wearing rigid contact lens

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (14)

• 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: 35196840 BACKGROUND

• 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: 26751993 BACKGROUND

• 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: 30130332 BACKGROUND

• 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: 32135543 BACKGROUND

• 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: 31203659 BACKGROUND

• 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: 33229668 BACKGROUND

• 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: 31558826 BACKGROUND

• 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: 34478004 BACKGROUND

• 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: 28025794 BACKGROUND

• 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: 33881809 BACKGROUND

• 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: 34441401 BACKGROUND

• 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: 24326332 BACKGROUND

• 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: 10815152 BACKGROUND

• 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.

  PMID: 29635068 BACKGROUND

MeSH Terms

Conditions

Eyelid Diseases; Blepharoptosis

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Yi-Hsuan Wei, PhD

  National Taiwan University Hospital, Department of Ophthalmology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 1, 2023
• Study Start: February 6, 2023
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: November 25, 2024

Record last verified: 2023-02

Locations

TW (1)