Effect of Upper Eyelid Surgeries on Corneal Characteristics

Eyelid Diseases Clinical Trial

Official title:

Effect of Upper Eyelid Surgeries on Corneal Topography, Corneal High-order Aberration, Corneal Biomechanical Properties, and Corneal Epithelial Thickness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750251
• Other study ID #: 202211048RINA
• Status: Recruiting
• Start date: February 6, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2023
• Source: National Taiwan University Hospital
• Contact: Yi-Hsuan Wei, PhD
• Phone: +886-2312-3456
• Email: ericwei224[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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. 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

Group 1:

• marginal reflex distance 1 (MRD1) ? 2-2.5 mm

• levator muscle function (LMF) ? 8 mm

Group 2:

• with upper scleral show

Exclusion Criteria:

• pregnancy

• previous corneal surgery

• with corneal scar

• pterygium

• keratoconus

• significant ocular surface disease

• wearing rigid contact lens

Related Conditions & MeSH terms

• Blepharoptosis
• Eyelid Diseases
• Ptosis, Eyelid

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from intraocular pressure at 3 months after the surgery	Measure intraocular pressure with tonometers in unit of mmHg	Baseline, Month 1, Month 3
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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