Kasr al ainy
Cairo, 11865, Egypt
NCT Number: NCT05358002
A prospective comparative study between the results obtained by applying frontalis muscle flap advancement and frontalis sling operations for correction of congenital ptosis with poor levator muscle function. Study will include evaluation of the functional and cosmetic results, recurrence rates, and the incidence and varieties of different complications between the two techniques
Looking for future studies?
Notify Me1 year–16 year
All sexes
Interventional
Not applicable
Cairo, 11865, Egypt
Criteria for inclusion in this study will be children more than 1 years age with:
Our study will be conducted on children with moderate to severe congenital ptosis with poor levator function attending the ophthalmology oculoplastic clinic of Abuelreesh children Hospital. At baseline, a detailed demographic and medical history will be collected, and the presence of an anomalous head posture is noted. All subjects will receive a complete preoperative ophthalmological evaluation. Slit-lamp examination, fundus examination and cycloplegic refraction will be done. Assessment of vision should be done according to the age, and the presence or absence of amblyopia is recorded. Best corrected visual acuity is also assessed if possible. Extraocular muscle functions will be evaluated for any associated abnormalities. All patients are tested for jaw winking syndrome and Bell's phenomenon.
The upper eyelid margin reflex distance (MRD1) will be measured which is the distance from the light reflex to the centre of the upper lid margin in primary position. The amount of ptosis is estimated by subtracting the MRD1 from 5 (5 - MRD1). The vertical interpalpebral fissure height will also be recorded. Measurement of levator muscle function is performed by measuring the excursion of the upper eyelid from downgaze to up gaze with the frontalis muscle fixed. Frontalis and orbicularis muscles functions are also assessed.
Patients will be divided randomly into two groups according to the technique used for correction of ptosis. We use the coin randomization method (Kang et al., 2008). Group A will undergo frontalis muscle flap advancement operation, while in group B, the children will be corrected by frontalis sling operation. Informed consent from the parents will be taken. All operations will be done under general anaesthesia and the incision sites will be marked using a surgical marker-pen in both techniques. Bupivacaine 0.5% with epinephrine 1:200,000 are infiltrated locally to improve intraoperative haemostasis and postoperative analgesia.
Surgical steps of frontalis muscle flap advancement technique:
Surgical steps of frontalis sling operation:
Patients will be seen for follow-up at the second postoperative day, 1 month, 3 months and 6 months. Our follow up will include MRD1, amount of residual ptosis, lid contour, cycloplegic refraction, lagophthalmos and corneal exposure, state of the scar, asymmetry of lid position in unilateral cases and other complications
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fashonizing a flap from frontalis muscle and connecting it to the tarsus of the upper eyelid
Time frame: About 6 months
Improvement of the marginal reflex distance that is measured by the ruler, which is the distance between the margin of the upper eyelid and the light reflex reflecting from the cornea from a torch against the cornea
Time frame: 6 months
Measuring the distance between margin of the upper and lower eyelid using a ruler
Cairo University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05132608
Unrecognized Condition
Dhulikhel, Bagmati, Nepal
View Trial DetailsNCT05929053
Behavior, Communication
Merkez, Artvin, Turkey (Türkiye)
View Trial DetailsNCT06464328
Anxiety Disorders, Behavior
Kota Bharu, Kelantan, Malaysia
View Trial DetailsNCT05908604
Unrecognized Condition
Kuopio, Finland
View Trial Details