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Effect of Upper Eyelid Surgeries on Corneal Characteristics

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National Taiwan University

Status

Completed

Conditions

Ptosis, Eyelid
Eyelid Diseases

Treatments

Procedure: Müller's muscle-conjuctival resection surgery
Procedure: full-thickness anterior blepharotomy surgery
Procedure: levator muscle resection surgery

Study type

Observational

Funder types

Other

Identifiers

NCT05750251
202211048RINA

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

13 participants in 2 patient groups

Ptosis patient
Description:
Undergo conventional ptosis correction surgery, including levator muscle resection surgery and Müller's muscle-conjuctival resection surgery
Treatment:
Procedure: levator muscle resection surgery
Procedure: Müller's muscle-conjuctival resection surgery
Eyelid retraction patient
Description:
Undergo conventional ptosis correction surgery, including full-thickness anterior blepharotomy surgery
Treatment:
Procedure: full-thickness anterior blepharotomy surgery

Trial contacts and locations

1

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Central trial contact

Jung-Je Yang, MD; Yi-Hsuan Wei, PhD

Data sourced from clinicaltrials.gov

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