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Completed

NCT Number: NCT05750251

Effect of Upper Eyelid Surgeries on Corneal Characteristics

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.

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Key information

Conditions

Eyelid Diseases Blepharoptosis Eye Diseases Ptosis, Eyelid

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

levator muscle resection surgery

Procedure

conventional ptosis surgery

Müller's muscle-conjuctival resection surgery

Procedure

conventional ptosis surgery

full-thickness anterior blepharotomy surgery

Procedure

conventional eyelid retraction surgery

Primary outcomes

  1. 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

  2. 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

  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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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

  10. 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

  11. 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)

  12. 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.

  13. 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.

  14. 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)

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2023
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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