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IRCT20200503047293N1 IRCT 2020-05-20 Research Institute of Ophthalmology Extra ocular muscle fenestration for surgical management of strabismus Extra ocular muscle fenestration as a weakening maneuver for surgical management of strabismus : A randomized pilot clinical trial 2020-06-01 anticipated 20 Complete https://irct.ir/trial/48091 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will use the sequentially numbered, opaque sealed envelopes method. We will use envelopes that are impermeable to intense light, and the allocation sequence will be concealed from the physicians enrolling and assessing participants. To prevent subversion of the allocation sequence, the name and hospital admission number of the participant will be written on the envelope. Carbon paper will transfer the information onto the allocation card inside the envelope. Corresponding envelopes will be opened only after the enrolled participants completes all baseline assessments and it is time to allocate the intervention, Blinding description: Since it is an operative procedure, only participants will be blinded to the type of intervention. N/A Strabismus. Intervention 1: Intervention group 1 (muscle fenestration): The rectus muscle will be exposed through a fornical conjunctival incision then the muscle will be stretched between 2 muscle hooks, and 2 peripheral muscle strips each 1 mm in width will be created using a fine muscle hook or by stripping the muscle fibers with a silk suture starting proximal at the desired site till the muscle insertion. Then, the 2 muscle strips will be separated on each side and the muscle belly in between will be excised leaving a bare sclera (a fenestration or a window defect). The conjunctiva will be re-positioned, and the surgery will be concluded. Intervention 2: Intervention group 2 (classic muscle recession): The muscle will be exposed by fornical incision. Dissection of the conjunctiva and tenon capsule will be done. Hooking of the muscle by Jameson hook and dissection of the intermuscular septum will be done. A Chavasse muscle hook will be exchanged with Jameson muscle hook, and the muscle will be secured with a coated double-armed Vicryl 6-0 suture with an s-29 needle. The desired amount of recession will be measured from the original insertion by a caliper. Scleral sutures will be taken at the superior and inferior edges parallel to the original insertion. The muscle will be pulled up to the level of the desired new insertion, making sure the sutures are taut and the muscle belly spreads nicely against the sclera. A knot will be tied with a double forehand throw, a single backhand throw, and a final single forehand throw. The sutures will then be cut 2 mm from knot. The conjunctiva is then closed with 2 interrupted Vicryl 8-0 sutures. Yes - There is a plan to make this available What will be shared: Extra ocular muscle fenestration IPD set (all collected deidentified IPD) When: beginning 6 months and ending 36 months following article publication To whom: Researchers from academic institutions whose proposal for the use of data has been approved by an independent review committee identified for this purpose Conditions: for IPD meta-analysis Where to obtain: from the PI How to obtain: A proposal for the use of data to be submitted to the PI, then evaluated by an independent review committee identified for this purpose Comments:
public Dr. Omar Hashem
2 El Ahram Street
Giza Egypt 12557 +20 2 35718304 hashemomar@yahoo.com Research Institute of Ophthalmology scientific Sameh Galal
2 El Ahram Street
Giza Egypt 12557 +20 2 35735688 sameh.galal.1900@gmail.com Research Institute of Ophthalmology Egypt Patients diagnosed with strabismus that requires surgical intervention after complete routine ophthalmological evaluation and evaluation of the angle of strabismus 1 year 60 years Both Previous strabismus surgery upon the target muscle Previous orbital surgery, orbital masses, or orbital inflammatory diseases H50.9 Unspecified strabismus Treatment - Surgery Treatment - Surgery Intervention group 1 (muscle fenestration): The rectus muscle will be exposed through a fornical conjunctival incision then the muscle will be stretched between 2 muscle hooks, and 2 peripheral muscle strips each 1 mm in width will be created using a fine muscle hook or by stripping the muscle fibers with a silk suture starting proximal at the desired site till the muscle insertion. Then, the 2 muscle strips will be separated on each side and the muscle belly in between will be excised leaving a bare sclera (a fenestration or a window defect). The conjunctiva will be re-positioned, and the surgery will be concluded. Intervention group 2 (classic muscle recession): The muscle will be exposed by fornical incision. Dissection of the conjunctiva and tenon capsule will be done. Hooking of the muscle by Jameson hook and dissection of the intermuscular septum will be done. A Chavasse muscle hook will be exchanged with Jameson muscle hook, and the muscle will be secured with a coated double-armed Vicryl 6-0 suture with an s-29 needle. The desired amount of recession will be measured from the original insertion by a caliper. Scleral sutures will be taken at the superior and inferior edges parallel to the original insertion. The muscle will be pulled up to the level of the desired new insertion, making sure the sutures are taut and the muscle belly spreads nicely against the sclera. A knot will be tied with a double forehand throw, a single backhand throw, and a final single forehand throw. The sutures will then be cut 2 mm from knot. The conjunctiva is then closed with 2 interrupted Vicryl 8-0 sutures. Ocular balance (post operative ocular alignment ). Timepoint: Second day, one week, and one month post-operative. Method of measurement: By corneal light reflex, Krimisky test, and prism cover test. Ocular motility (freedom vs limitations). Timepoint: Second day, one week, and one month post-operative. Method of measurement: Assessment of versions and ductions. Post-operative pain. Timepoint: Second day, one week, and one month post-operative. Method of measurement: Asking the patient about post operative pain and giving a pain score from 1 to 5. Self-funded Approved 2020-02-23 Research Ethical Committee of the Research Institute of Ophthalmology 2 El Ahram Street Giza Cairo Egypt