Effect of Upper Eyelid Surgeries on Corneal Characteristics

November 20, 2024 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from best corrected visual acuity at 3 months after the surgery
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
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
Time Frame: Baseline, Month 1, Month 3
Measure corneal epithelial thickness with anterior segment optical coherence tomography in unit of micrometer (Visionix USA, Illinois, USA)
Baseline, Month 1, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Yi-Hsuan Wei, PhD, National Taiwan University Hospital, Department of Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Actual)

July 10, 2023

Study Completion (Actual)

July 10, 2023

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202211048RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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