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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
- Population of study & disease condition: Congenital ptosis with poor levator muscle function.
- Study setting: The ophthalmology unit of Abuelreesh Children Hospital.
- Inclusion criteria:
Criteria for inclusion in this study will be children more than 1 years age with:
moderate to severe ptosis with margin reflex distance1 (MRD1) ≤2 mm,
poor levator function of <4 mm,
good frontalis muscle function.
Exclusion criteria:
Methodology in details:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frontalis sling | Active Comparator | Connecting the frontalis muscle action with the tarsus of the upper eyelid with synthetic material PTFE ( gore-tex ) |
|
| Frontalis flap | Experimental | Fashonizing a flap from frontalis muscle and connecting it to the tarsus of the upper eyelid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frontalis flap | Procedure | Fashonizing a flap from frontalis muscle and connecting it to the tarsus of the upper eyelid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of MRD ( marginal reflex distance ) | 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 | About 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of the vertical palpebral fissure height | Measuring the distance between margin of the upper and lower eyelid using a ruler | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magda S Abdelaziz, Prof. | Kasr alainy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr al ainy | Cairo | 11865 | Egypt |
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