Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05358002 |
| Other study ID # |
MD-93-2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 20, 2020 |
| Est. completion date |
April 9, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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
Description:
- 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:
1. moderate to severe ptosis with margin reflex distance1 (MRD1) ≤2 mm,
2. poor levator function of <4 mm,
3. good frontalis muscle function.
- Exclusion criteria:
1. Children with no Bell's phenomenon, the Marcus Gunn phenomenon, myasthenia
gravis, strabismus, and blepharophimosis syndrome.
2. Children with history of previous ptosis surgery or lid trauma.
- 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:
1. A lid-crease incision is made 4-5 mm above the lash line or according to the height of
the opposite lid crease starting lateral to the supraorbital notch.
2. The incision is made deep to the plane beneath the orbicularis oculi and the dissection
is upward as far as 0.5-1 mm above the superior margin of the eyebrow.
3. A strip of orbicularis, about 1-2 mm wide, is excised from the lower margin of the
incision exposing the anterior surface of the tarsal plate.
4. Two parallel cuts, 1.5-2 cm apart, are made cephalad at the middle third of the
myofascial tissue between the two dissected planes, forming a superiorly based
rectangular myofascial flap that can be drawn downward freely.
5. A 15×20mm quadrangular frontalis muscle flap is dissected and pulled down. The free flap
border is then attached to the upper third of tarsal plate with three 6-0 polypropylene
sutures.
6. The central suture (highest point) determines the level of the upper-eyelid margin (just
nasal to the pupil level). The eyelid margin is set at or 1 mm above the limbus.
7. The medial and lateral sutures are attached at the level of the medial and lateral
limbus, respectively. Two additional sutures are applied along the line of fixation to
form a smooth line if necessary.
8. After adjusting the fixation level properly, the redundant muscle is trimmed and the
skin is closed with polypropylene 6-0 continuous suture.
9. A compressive patch will be applied for 24 hours.
Surgical steps of frontalis sling operation:
1. An eyelid spatula with ointment will be placed under the ptosed lid to prevent ocular
trauma during skin incision and when the needle is passed.
2. Three stab incisions (3mm) in the lid will be made 2 mm from the lid margin. These
incisions will be done through the skin and orbicularis muscle to expose the tarsus.
3. Two brow incisions, down to the level of periosteum, will be made just above the brow
hairs, approximately in line with the lateral and medial canthi.
4. A forehead incision approximately (8-10 mm) above the brow, down to periosteum, will be
placed midway between the 2 brow incisions.
5. A pocket will be dissected superiorly beneath the frontalis muscle, with blunt scissors,
in the central forehead incision.
6. Sling material stringing will be performed using Wright needle.
7. Frontalis sling suspension will be done using Crawford procedure (double triangle
configurations).
8. The sling material used will be polytetrafluoroethylene (PTFE) 2-0 suture material.
9. The lid contour and height will be adjusted by pulling on the ends of sling material.
The eyelid margin is elevated to (or 1 mm above) the superior limbus of the cornea. The
nasal third will be slightly higher than the lateral third.
10. Both ends of the sling will be tied together. The ends of sling material will be trimmed
about 3 mm from the knot and the knot is buried into the preformed pocket.
11. The brow and forehead skin incisions are closed using 6-0 polyglycolic 610 sutures. In
both groups, All patients will be prescribed topical antibiotic ointment for skin wounds
for one week. Frequent lubricant eye drops every 1 hour and lubricant gel every 2 hours
and before sleeping, will be applied for the early postoperative period. Then the
medication intervals will be adjusted according to lagophthalmos and exposure
keratopathy. The sutures will be removed 5-7 days after surgery. In group A, after the
third day, alternating eyelid opening (with the frontalis muscle) and closing movements
(with the orbicularis muscle) are started to reduce adherence of the muscle flap to the
surrounding structures.
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
