Upper Eyelid DynamicsNCT06976645
Upper Eyelid Dynamics in Pediatric Blepharoptosis Using High Speed Videography
A study testing Levator muscle resection in people with Upper Eyelid Dynamics, run by Minia University.
Trial summary
Evaluation of the Upper Eyelid Dynamics in Simple Congenital Blepharoptosis before and after Levator Muscle Resection Using High speed Photography Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Eyelid Dynamics
- What is being tested?
- Levator muscle resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients who are diagnosed as simple congenital ptosis with fair to good levator function (≥5 mm lid elevation) with age range from 5 to 18 years old.
Who cannot join
- Patients with a history of previous eyelid surgery or trauma
- Blepharophamosis and Marcus Gun Jaw-winking syndrome
- Patients with associated neurological disorders
- Patients with craniofacial abnormalities
- Patients with suspected myasthenia or myopathies
- Patients with absent Bell's phenomenon
- Patients with dry eye
- Uncooperative patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Zamzam Mohamed Alham, Assistant lecturer contact
About this study
Official title: Evaluation of the Upper Eyelid Dynamics in Simple Congenital Blepharoptosis Before and After Levator Muscle Resection Using High Speed Videography
Evaluation of the Upper Eyelid Dynamics in Simple Congenital Blepharoptosis before and after Levator Muscle Resection Using High speed Photography
Read the detailed description
Normal eyelid dynamics are essential for optimum performance and protection of the eye including distribution of the pre-corneal tear film, clearance of debris, stimulation of Meibomian gland secretion, and assistance of tear drainage via generating negative pressure in the lacrimal sac. Conversely, abnormal eyelid dynamics can have a variety of implications in ocular surface health and visual function.1 Current methods for evaluating eyelid dynamics include magnetic-based devices, high-speed videography, infrared videography, and direct observation.2-3 Whereas magnetic search coils are considered the gold standard for research purposes, they may not be practical at the clinical setting. Conversely, a readily available and cost-effective technology of smartphone video cameras with high speed video photography options has reached a level of perfection that may enable them to be used for objective and quantative slow motion analysis of eyelid dynamics.
The interest in the study of lid dynamics started early in 1977 through dynamic measurements made with a mechanical transducer connected physically to the upper eyelid. 4 The normal spontaneous blink rate has a wide variability, ranging from 2 to 50 blinks per minute. It is reported that normal blink duration varies from 300 to 572 milliseconds. Normal blink amplitudes also vary from 7.4 to 12.8 mm and decrease with age.5-6,7-8 Most of these values have been established with different techniques for analysis with magnetic search coil.6,7,9 High-speed cameras provide precise, measurable movement detection.9 With these cameras, the upper and lower eyelids have shown to both move also horizontally during the closure phase of eyelid blinking.7 Previous studies measured the spontaneous eyelid blink dynamic changes using a high-speed camera in various conditions as age-related changes5, following upper eyelid blepharoplasty and its association with dry eye10 and in patients with thyroid disease11.
Upper eyelid surgery can change the lid dynamics. For instance, incomplete lid closure is sometimes encountered after upper blepharoplasty. The most common cause of lagophthalmos is excessive skin resection, which acts as a negative passive force that is much stronger than the active closing force of the orbicularis oculi muscle and can disturb blinking .12 Congenital ptosis is the presence of an abnormally low position of the upper eyelid, with respect to the visual axis in the primary gaze .13 It may not be immediately noticeable after birth but is usually manifest within a few months. It can be unilateral or bilateral. It has a significant functional and psychosocial impact on the child.14The underlying etiology appears to be localized muscle dysgenesis. In the affected levator muscle fibers are infiltrated or replaced with fibrous and adipose tissue, which results in abnormal contraction and relaxation .15 There is an association between congenital ptosis and under action of the superior rectus muscle in up to 25% of unilateral cases and in 65% of bilateral cases .16 It may be associated with lagophthalmos on downgaze with exposure of the cornea. There is often a decreased or absent lid crease .13 Levator resection is the gold standard of surgical correction of simple congenital ptosis with fair to good levator function. It creates optimal lid contour and symmetry with relatively desirable cosmetic outcomes17-19. Lagophthalmos is one of the surgical consequences. It usually improves with time .20 In the study of Cruz et al.,2014 21 on supramaximal levator resection, spontaneous blinks were abnormal in 93% of the operated eyelids. The mean amplitude of the abnormal blinks was 37.1% of the contralateral eyelids. Downward eyelid saccades were reduced in 79% of the eyelids.
To the best of our knowledge this is the first study to assess the changes of eyelid dynamics in patients with simple congenital ptosis before and after levator muscle resection using high speed video photography. Aim of the study
Quantative subjective analysis of upper eyelid dynamics in patients with simple congenital ptosis before and after levator muscle resection using high speed video recording.
- Conditions
- Upper Eyelid Dynamics
- Being tested
- Levator muscle resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levator muscle resectionProcedure or surgery
Levator muscle resection
| Study group | Role | What they receive |
|---|---|---|
| Levatot muscle resection | Other | Levator muscle resection for correction of upper eyelid congenital blepharoptosis Receives: Procedure: Levator muscle resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the changes of blinking velocity before and after levator resection in patients with congenital ptosis
Record the changes of blinking velocity in patients with congenital ptosis before and after levator resection \&normal patients in same age group using high speed videography to detect changes in blinking velocity .
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Upper Eyelid DynamicsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zamzam Mohamed Alham, Minia University
- Investigators
- Ahmed Mohamed Elshafei, Professor, Study director, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976645
- Sponsor's protocol ID
- UEL dynamics in cong.ptosis
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hung G, Hsu F, Stark L. Dynamics of the human eyeblink. Am J Optom Physiol Opt. 1977 Oct;54(10):678-90. doi: 10.1097/00006324-197710000-00005.
PubMed 605924DeAngelis KD, Rider A, Potter W, Jensen J, Fowler BT, Fleming JC. Eyelid Spontaneous Blink Analysis and Age-Related Changes Through High-Speed Imaging. Ophthalmic Plast Reconstr Surg. 2019 Sep/Oct;35(5):487-490. doi: 10.1097/IOP.0000000000001349.
PubMed 30844914Mak FHW, Ting M, Edmunds MR, Harker A, Edirisinghe M, Duggineni S, Murta F, Ezra DG. Videographic Analysis of Blink Dynamics following Upper Eyelid Blepharoplasty and Its Association with Dry Eye. Plast Reconstr Surg Glob Open. 2020 Jul 21;8(7):e2991. doi: 10.1097/GOX.0000000000002991. eCollection 2020 Jul.
PubMed 32802679Wuthisiri W, Peou C, Lekskul A, Chokthaweesak W. Maximal Levator Resection Beyond Whitnall's Ligament in Severe Simple Congenital Ptosis with Poor Levator Function. Clin Ophthalmol. 2022 Feb 17;16:441-452. doi: 10.2147/OPTH.S340781. eCollection 2022.
PubMed 35210749Allard FD, Durairaj VD. Current techniques in surgical correction of congenital ptosis. Middle East Afr J Ophthalmol. 2010 Apr;17(2):129-33. doi: 10.4103/0974-9233.63073.
PubMed 20616918
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Upper Eyelid Dynamics in Simple Congenital Blepharoptosis Before and After Levator Muscle Resection Using High Speed Videography
- ClinicalTrials.gov ID
- NCT06976645
- Acronym / sponsor ID
- UEL dynamics in cong.ptosis
- Conditions
- Upper Eyelid Dynamics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 16 May 2025 (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.
Evaluation of the Upper Eyelid Dynamics in Simple Congenital Blepharoptosis before and after Levator Muscle Resection Using High speed Photography
Detailed description
Normal eyelid dynamics are essential for optimum performance and protection of the eye including distribution of the pre-corneal tear film, clearance of debris, stimulation of Meibomian gland secretion, and assistance of tear drainage via generating negative pressure in the lacrimal sac. Conversely, abnormal eyelid dynamics can have a variety of implications in ocular surface health and visual function.1 Current methods for evaluating eyelid dynamics include magnetic-based devices, high-speed videography, infrared videography, and direct observation.2-3 Whereas magnetic search coils are considered the gold standard for research purposes, they may not be practical at the clinical setting. Conversely, a readily available and cost-effective technology of smartphone video cameras with high speed video photography options has reached a level of perfection that may enable them to be used for objective and quantative slow motion analysis of eyelid dynamics.
The interest in the study of lid dynamics started early in 1977 through dynamic measurements made with a mechanical transducer connected physically to the upper eyelid. 4 The normal spontaneous blink rate has a wide variability, ranging from 2 to 50 blinks per minute. It is reported that normal blink duration varies from 300 to 572 milliseconds. Normal blink amplitudes also vary from 7.4 to 12.8 mm and decrease with age.5-6,7-8 Most of these values have been established with different techniques for analysis with magnetic search coil.6,7,9 High-speed cameras provide precise, measurable movement detection.9 With these cameras, the upper and lower eyelids have shown to both move also horizontally during the closure phase of eyelid blinking.7 Previous studies measured the spontaneous eyelid blink dynamic changes using a high-speed camera in various conditions as age-related changes5, following upper eyelid blepharoplasty and its association with dry eye10 and in patients with thyroid disease11.
Upper eyelid surgery can change the lid dynamics. For instance, incomplete lid closure is sometimes encountered after upper blepharoplasty. The most common cause of lagophthalmos is excessive skin resection, which acts as a negative passive force that is much stronger than the active closing force of the orbicularis oculi muscle and can disturb blinking .12 Congenital ptosis is the presence of an abnormally low position of the upper eyelid, with respect to the visual axis in the primary gaze .13 It may not be immediately noticeable after birth but is usually manifest within a few months. It can be unilateral or bilateral. It has a significant functional and psychosocial impact on the child.14The underlying etiology appears to be localized muscle dysgenesis. In the affected levator muscle fibers are infiltrated or replaced with fibrous and adipose tissue, which results in abnormal contraction and relaxation .15 There is an association between congenital ptosis and under action of the superior rectus muscle in up to 25% of unilateral cases and in 65% of bilateral cases .16 It may be associated with lagophthalmos on downgaze with exposure of the cornea. There is often a decreased or absent lid crease .13 Levator resection is the gold standard of surgical correction of simple congenital ptosis with fair to good levator function. It creates optimal lid contour and symmetry with relatively desirable cosmetic outcomes17-19. Lagophthalmos is one of the surgical consequences. It usually improves with time .20 In the study of Cruz et al.,2014 21 on supramaximal levator resection, spontaneous blinks were abnormal in 93% of the operated eyelids. The mean amplitude of the abnormal blinks was 37.1% of the contralateral eyelids. Downward eyelid saccades were reduced in 79% of the eyelids.
To the best of our knowledge this is the first study to assess the changes of eyelid dynamics in patients with simple congenital ptosis before and after levator muscle resection using high speed video photography. Aim of the study
Quantative subjective analysis of upper eyelid dynamics in patients with simple congenital ptosis before and after levator muscle resection using high speed video recording.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levatot muscle resection | Other | Procedure: Levator muscle resectionLevator muscle resection for correction of upper eyelid congenital blepharoptosis |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients who are diagnosed as simple congenital ptosis with fair to good levator function (≥5 mm lid elevation) with age range from 5 to 18 years old.
Key exclusion criteria (8 listed)
- Patients with a history of previous eyelid surgery or trauma
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 resectionLevator muscle resection | Procedure or surgery | Levatot muscle resection |
Primary outcome
Determine the changes of blinking velocity before and after levator resection in patients with congenital ptosis
Time frame: One year
Record the changes of blinking velocity in patients with congenital ptosis before and after levator resection \&normal patients in same age group using high speed videography to detect changes in blinking velocity .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 605924Hung G, Hsu F, Stark L. Dynamics of the human eyeblink. Am J Optom Physiol Opt. 1977 Oct;54(10):678-90. doi: 10.1097/00006324-197710000-00005.
- Background: PubMed 30844914DeAngelis KD, Rider A, Potter W, Jensen J, Fowler BT, Fleming JC. Eyelid Spontaneous Blink Analysis and Age-Related Changes Through High-Speed Imaging. Ophthalmic Plast Reconstr Surg. 2019 Sep/Oct;35(5):487-490. doi: 10.1097/IOP.0000000000001349.
- Background: PubMed 32802679Mak FHW, Ting M, Edmunds MR, Harker A, Edirisinghe M, Duggineni S, Murta F, Ezra DG. Videographic Analysis of Blink Dynamics following Upper Eyelid Blepharoplasty and Its Association with Dry Eye. Plast Reconstr Surg Glob Open. 2020 Jul 21;8(7):e2991. doi: 10.1097/GOX.0000000000002991. eCollection 2020 Jul.
- Background: PubMed 35210749Wuthisiri W, Peou C, Lekskul A, Chokthaweesak W. Maximal Levator Resection Beyond Whitnall's Ligament in Severe Simple Congenital Ptosis with Poor Levator Function. Clin Ophthalmol. 2022 Feb 17;16:441-452. doi: 10.2147/OPTH.S340781. eCollection 2022.
- Background: PubMed 20616918Allard FD, Durairaj VD. Current techniques in surgical correction of congenital ptosis. Middle East Afr J Ophthalmol. 2010 Apr;17(2):129-33. doi: 10.4103/0974-9233.63073.
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.
Zamzam Mohamed Alham, Assistant lecturer contact
Ahmed Mohamed Elshafei, Professor study director
Minia University
Questions about this trial
What is this clinical trial studying?
A study testing Levator muscle resection in people with Upper Eyelid Dynamics, run by Minia University.
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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zamzam Mohamed Alham, Assistant lecturer (+201016909914 ext. +201224222252, yassozoma2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the changes of blinking velocity before and after levator resection in patients with congenital ptosis (time frame: One year). 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 NCT06976645, which also lists 5 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 16 May 2025.