Clinical trial NCT05750251: Effect of Upper Eyelid Surgeries on Corneal Characteristics
Official title: Effect of Upper Eyelid Surgeries on Corneal Topography, Corneal High-order Aberration, Corneal Biomechanical Properties, and Corneal Epithelial Thickness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eyelid Diseases
Ptosis, Eyelid
Keywords: Blepharoplasty
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from best corrected visual acuity at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from intraocular pressure at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from eyeball axial length at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from slit lamp examination at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from margin to reflex distance (MRD) at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from levator muscle function (LMF) at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from lagophthalmos at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from basal tear volume at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from ocular surface disease index (OSDI) at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from tear break up time at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from corneal biomechanical characteristics at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from corneal topography at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from higher-order corneal aberrations at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
measure: Change from corneal epithelial thickness at 3 months after the surgery
timeFrame: Baseline, Month 1, Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital, Department of Ophthalmology
name: Yi-Hsuan Wei, PhD
role: STUDY_CHAIR
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