NCT06976645

Brief Summary

Evaluation of the Upper Eyelid Dynamics in Simple Congenital Blepharoptosis before and after Levator Muscle Resection Using High speed Photography

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jul 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 2025Jul 2026

First Submitted

Initial submission to the registry

April 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 16, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

April 3, 2025

Last Update Submit

May 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 .

    One year

Study Arms (1)

Levatot muscle resection

OTHER

Levator muscle resection for correction of upper eyelid congenital blepharoptosis

Procedure: Levator muscle resection

Interventions

Levator muscle resection

Levatot muscle resection

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 605924BACKGROUND
  • DeAngelis 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.

    PMID: 30844914BACKGROUND
  • Mak 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.

    PMID: 32802679BACKGROUND
  • Wuthisiri 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.

    PMID: 35210749BACKGROUND
  • Allard 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.

    PMID: 20616918BACKGROUND

Study Officials

  • Ahmed Mohamed Elshafei, Professor

    Minia University

    STUDY DIRECTOR

Central Study Contacts

Zamzam Mohamed Alham, Assistant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 3, 2025

First Posted

May 16, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 16, 2025

Record last verified: 2025-04