Eyelid DiseasesNCT05750251
Effect of Upper Eyelid Surgeries on Corneal Characteristics
An observational study of Eyelid Diseases and Ptosis, Eyelid, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Eyelid Diseases, Ptosis, Eyelid
- What is being tested?
- levator muscle resection surgery, Müller's muscle-conjuctival resection surgery and full-thickness anterior blepharotomy surgery
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Feb 2023to 10 Jul 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Group 1:
- marginal reflex distance 1 (MRD1) ≦ 2-2.5 mm
- levator muscle function (LMF) ≧ 8 mm
- Group 2:
- with upper scleral show
Who cannot join
- pregnancy
- previous corneal surgery
- with corneal scar
- pterygium
- keratoconus
- significant ocular surface disease
- wearing rigid contact lens
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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: •
- Changes in corneal topography, higher-order corneal aberrations, corneal biomechanical characteristics, and corneal epithelial thickness before and after the surgery
- 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.
Read the 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.
- Conditions
- Eyelid Diseases, Ptosis, Eyelid
- Being tested
- levator muscle resection surgery, Müller's muscle-conjuctival resection surgery, full-thickness anterior blepharotomy surgery
- Keywords
- Blepharoplasty
- Medical subject headings
- Eyelid Diseases, Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levator muscle resection surgeryProcedure or surgery
conventional ptosis surgery
Müller's muscle-conjuctival resection surgeryProcedure or surgery
conventional ptosis surgery
full-thickness anterior blepharotomy surgeryProcedure or surgery
conventional eyelid retraction surgery
| Study group | Role | What they receive |
|---|---|---|
| Ptosis patient | Undergo conventional ptosis correction surgery, including levator muscle resection surgery and Müller's muscle-conjuctival resection surgery Receives: Procedure: levator muscle resection surgery; Procedure: Müller's muscle-conjuctival resection surgery | |
| Eyelid retraction patient | Undergo conventional ptosis correction surgery, including full-thickness anterior blepharotomy surgery Receives: Procedure: full-thickness anterior blepharotomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Month 1, Month 3
Change from intraocular pressure at 3 months after the surgery
Measure intraocular pressure with tonometers in unit of mmHg
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Baseline, Month 1, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start6 Feb 2023
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Eyelid DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Hsuan Wei, PhD, Study chair, National Taiwan University Hospital, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750251
- Sponsor's protocol ID
- 202211048RINA
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
Aksu Ceylan N, Yeniad B. Effects of Upper Eyelid Surgery on the Ocular Surface and Corneal Topography. Turk J Ophthalmol. 2022 Feb 23;52(1):50-56. doi: 10.4274/tjo.galenos.2021.63255.
PubMed 35196840Savino G, Battendieri R, Riso M, Traina S, Poscia A, D'Amico G, Caporossi A. Corneal Topographic Changes After Eyelid Ptosis Surgery. Cornea. 2016 Apr;35(4):501-5. doi: 10.1097/ICO.0000000000000729.
PubMed 26751993Ozturk Karabulut G, Fazil K. Corneal Topographical Changes After Muller's Muscle-conjunctival Resection Surgery. Ophthalmic Plast Reconstr Surg. 2019 Mar/Apr;35(2):177-181. doi: 10.1097/IOP.0000000000001203.
PubMed 30130332Zloto O, Matani A, Sagiv O, Prat D, Ben Artsi E, Leshno A, Priel A, Ben Simon GJ. Changes in Refraction and Visual Acuity after Upper Eyelid Blepharoplasty versus Posterior Approach Ptosis Procedures. Ophthalmic Res. 2020;63(6):588-592. doi: 10.1159/000506951. Epub 2020 Mar 5.
PubMed 32135543Altin Ekin M, Karadeniz Ugurlu S. Prospective analysis of visual function changes in patients with dermatochalasis after upper eyelid blepharoplasty. Eur J Ophthalmol. 2020 Sep;30(5):978-984. doi: 10.1177/1120672119857501. Epub 2019 Jun 17.
PubMed 31203659Bhattacharjee K, Misra D, Singh M, Deori N. Long-term changes in contrast-sensitivity, corneal topography and higher-order aberrations after upper eyelid blepharoplasty: A prospective interventional study. Indian J Ophthalmol. 2020 Dec;68(12):2906-2910. doi: 10.4103/ijo.IJO_907_20.
PubMed 33229668Li X, Liu C, Mao Z, Liang X, Li Z, Liu X, Gong R, Huang D. Effect of congenital blepharoptosis on corneal biomechanical properties and changes after ptosis surgery. Eye (Lond). 2020 Jun;34(6):1055-1062. doi: 10.1038/s41433-019-0586-9. Epub 2019 Sep 26.
PubMed 31558826Sommer F, Untch E, Spoerl E, Herber R, Pillunat LE, Terai N. Effect of upper eyelid blepharoplasty on corneal biomechanical, topographic and tomographic parameters 4 weeks after surgery. Int Ophthalmol. 2022 Jan;42(1):113-121. doi: 10.1007/s10792-021-02006-6. Epub 2021 Sep 3.
PubMed 34478004Dogan AS, Acar M, Kosker M, Arslan N, Gurdal C. Alterations in corneal epithelial thickness in patients with congenital myogenic eyelid ptosis. Int Ophthalmol. 2018 Feb;38(1):53-57. doi: 10.1007/s10792-016-0419-9. Epub 2016 Dec 26.
PubMed 28025794Yamamoto R, Ono T, Toyono T, Shirakawa R, Noda M, Yoshida J, Miyai T. Assessment of Long-Term Anterior and Posterior Topographic Changes in the Cornea After Ptosis Surgery Using Fourier Harmonic Analysis. Cornea. 2021 Apr;40(4):440-444. doi: 10.1097/ICO.0000000000002429.
PubMed 33881809Kanclerz P, Khoramnia R, Wang X. Current Developments in Corneal Topography and Tomography. Diagnostics (Basel). 2021 Aug 13;11(8):1466. doi: 10.3390/diagnostics11081466.
PubMed 34441401Grubbs JR Jr, Tolleson-Rinehart S, Huynh K, Davis RM. A review of quality of life measures in dry eye questionnaires. Cornea. 2014 Feb;33(2):215-8. doi: 10.1097/ICO.0000000000000038.
PubMed 24326332Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
PubMed 10815152Ang M, Baskaran M, Werkmeister RM, Chua J, Schmidl D, Aranha Dos Santos V, Garhofer G, Mehta JS, Schmetterer L. Anterior segment optical coherence tomography. Prog Retin Eye Res. 2018 Sep;66:132-156. doi: 10.1016/j.preteyeres.2018.04.002. Epub 2018 Apr 7.
PubMed 29635068
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Upper Eyelid Surgeries on Corneal Topography, Corneal High-order Aberration, Corneal Biomechanical Properties, and Corneal Epithelial Thickness
- ClinicalTrials.gov ID
- NCT05750251
- Acronym / sponsor ID
- 202211048RINA
- Conditions
- Eyelid Diseases, Ptosis, Eyelid
- Keywords
- Blepharoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: •
- Changes in corneal topography, higher-order corneal aberrations, corneal biomechanical characteristics, and corneal epithelial thickness before and after the surgery
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ptosis patient | – | Procedure: levator muscle resection surgery, Procedure: Müller's muscle-conjuctival resection surgeryUndergo conventional ptosis correction surgery, including levator muscle resection surgery and Müller's muscle-conjuctival resection surgery |
| Eyelid retraction patient | – | Procedure: full-thickness anterior blepharotomy surgeryUndergo conventional ptosis correction surgery, including full-thickness anterior blepharotomy surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- marginal reflex distance 1 (MRD1) ≦ 2-2.5 mm
- levator muscle function (LMF) ≧ 8 mm
- with upper scleral show
Key exclusion criteria (7 listed)
- pregnancy
- previous corneal surgery
- with corneal scar
- pterygium
- keratoconus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levator muscle resection surgeryconventional ptosis surgery | Procedure or surgery | Ptosis patient |
| Müller's muscle-conjuctival resection surgeryconventional ptosis surgery | Procedure or surgery | Ptosis patient |
| full-thickness anterior blepharotomy surgeryconventional eyelid retraction surgery | Procedure or surgery | Eyelid retraction patient |
Primary outcome
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
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
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
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
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
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
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
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.
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
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
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)
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.
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Background: PubMed 35196840Aksu Ceylan N, Yeniad B. Effects of Upper Eyelid Surgery on the Ocular Surface and Corneal Topography. Turk J Ophthalmol. 2022 Feb 23;52(1):50-56. doi: 10.4274/tjo.galenos.2021.63255.
- Background: PubMed 26751993Savino G, Battendieri R, Riso M, Traina S, Poscia A, D'Amico G, Caporossi A. Corneal Topographic Changes After Eyelid Ptosis Surgery. Cornea. 2016 Apr;35(4):501-5. doi: 10.1097/ICO.0000000000000729.
- Background: PubMed 30130332Ozturk Karabulut G, Fazil K. Corneal Topographical Changes After Muller's Muscle-conjunctival Resection Surgery. Ophthalmic Plast Reconstr Surg. 2019 Mar/Apr;35(2):177-181. doi: 10.1097/IOP.0000000000001203.
- Background: PubMed 32135543Zloto O, Matani A, Sagiv O, Prat D, Ben Artsi E, Leshno A, Priel A, Ben Simon GJ. Changes in Refraction and Visual Acuity after Upper Eyelid Blepharoplasty versus Posterior Approach Ptosis Procedures. Ophthalmic Res. 2020;63(6):588-592. doi: 10.1159/000506951. Epub 2020 Mar 5.
- Background: PubMed 31203659Altin Ekin M, Karadeniz Ugurlu S. Prospective analysis of visual function changes in patients with dermatochalasis after upper eyelid blepharoplasty. Eur J Ophthalmol. 2020 Sep;30(5):978-984. doi: 10.1177/1120672119857501. Epub 2019 Jun 17.
- Background: PubMed 33229668Bhattacharjee K, Misra D, Singh M, Deori N. Long-term changes in contrast-sensitivity, corneal topography and higher-order aberrations after upper eyelid blepharoplasty: A prospective interventional study. Indian J Ophthalmol. 2020 Dec;68(12):2906-2910. doi: 10.4103/ijo.IJO_907_20.
- Background: PubMed 31558826Li X, Liu C, Mao Z, Liang X, Li Z, Liu X, Gong R, Huang D. Effect of congenital blepharoptosis on corneal biomechanical properties and changes after ptosis surgery. Eye (Lond). 2020 Jun;34(6):1055-1062. doi: 10.1038/s41433-019-0586-9. Epub 2019 Sep 26.
- Background: PubMed 34478004Sommer F, Untch E, Spoerl E, Herber R, Pillunat LE, Terai N. Effect of upper eyelid blepharoplasty on corneal biomechanical, topographic and tomographic parameters 4 weeks after surgery. Int Ophthalmol. 2022 Jan;42(1):113-121. doi: 10.1007/s10792-021-02006-6. Epub 2021 Sep 3.
- Background: PubMed 28025794Dogan AS, Acar M, Kosker M, Arslan N, Gurdal C. Alterations in corneal epithelial thickness in patients with congenital myogenic eyelid ptosis. Int Ophthalmol. 2018 Feb;38(1):53-57. doi: 10.1007/s10792-016-0419-9. Epub 2016 Dec 26.
- Background: PubMed 33881809Yamamoto R, Ono T, Toyono T, Shirakawa R, Noda M, Yoshida J, Miyai T. Assessment of Long-Term Anterior and Posterior Topographic Changes in the Cornea After Ptosis Surgery Using Fourier Harmonic Analysis. Cornea. 2021 Apr;40(4):440-444. doi: 10.1097/ICO.0000000000002429.
- Background: PubMed 34441401Kanclerz P, Khoramnia R, Wang X. Current Developments in Corneal Topography and Tomography. Diagnostics (Basel). 2021 Aug 13;11(8):1466. doi: 10.3390/diagnostics11081466.
- Background: PubMed 24326332Grubbs JR Jr, Tolleson-Rinehart S, Huynh K, Davis RM. A review of quality of life measures in dry eye questionnaires. Cornea. 2014 Feb;33(2):215-8. doi: 10.1097/ICO.0000000000000038.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Hsuan Wei, PhD study chair
National Taiwan University Hospital, Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eyelid Diseases and Ptosis, Eyelid, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from best corrected visual acuity at 3 months after the surgery (time frame: Baseline, Month 1, Month 3). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05750251, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.