An observational study in Eyelid Diseases and Ptosis, Eyelid, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by National Taiwan University Hospital · Observational
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: •
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.
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.
26 studies on the registry are indexed under Eyelid Diseases; 3 are open to participants now.
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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.
Group 1:
Group 2:
Exclusion Criteria:
Undergo conventional ptosis correction surgery, including levator muscle resection surgery and Müller's muscle-conjuctival resection surgery
Procedure: levator muscle resection surgery · Procedure: Müller's muscle-conjuctival resection surgery
Undergo conventional ptosis correction surgery, including full-thickness anterior blepharotomy surgery
Procedure: full-thickness anterior blepharotomy surgery
conventional ptosis surgery
conventional ptosis surgery
conventional eyelid retraction surgery
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
Time frame: Baseline, Month 1, Month 3
Change from intraocular pressure at 3 months after the surgery
Measure intraocular pressure with tonometers in unit of mmHg
Time frame: Baseline, Month 1, Month 3
Change from eyeball axial length at 3 months after the surgery
Measure eyeball axial length with A-scan in unit of mm
Time frame: Baseline, Month 1, Month 3
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
Time frame: Baseline, Month 1, Month 3
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
Time frame: Baseline, Month 1, Month 3
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
Time frame: Baseline, Month 1, Month 3
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
Time frame: Baseline, Month 1, Month 3
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.
Time frame: Baseline, Month 1, Month 3
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
Time frame: Baseline, Month 1, Month 3
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
Time frame: Baseline, Month 1, Month 3
Change from corneal biomechanical characteristics at 3 months after the surgery
Measure corneal biomechanical characteristics with Oculus Corvis ST tonometer (OCULUS, Wetzlar, Germany)
Time frame: Baseline, Month 1, Month 3
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.
Time frame: Baseline, Month 1, Month 3
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.
Time frame: Baseline, Month 1, Month 3
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)
Time frame: Baseline, Month 1, Month 3
Plan to share: Undecided — Undecided
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital