To evaluate the efficacy and safety of fenestration as a weakening maneuver to horizontal and vertical extra ocular muscles in the surgical management of strabismus
Design
Parallel group, controlled, randomized trial with 1:1 allocation ratio
Settings and conduct
Pediatric Ophthalmology and Strabismus Department at the Research Institute of Ophthalmology
Participants/Inclusion and exclusion criteria
We will include patients (male or female, from 1 to 60 years-old) with strabismus that requires surgical intervention with diagnosis after:
1. Complete routine ophthalmological evaluation.
2. Evaluation of the angle of strabismus to and deciding the amount of needed weakening.
We will exclude patients with
1. with previous strabismus surgery upon the target muscle to be weakened.
2. with previous orbital surgery, orbital masses, or orbital inflammatory diseases.
Intervention groups
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. The 2 muscle strips will then 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.
Extra ocular muscle fenestration as a weakening maneuver for surgical management of strabismus : A randomized pilot clinical trial
Public title
Extra ocular muscle fenestration for surgical management of strabismus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with strabismus that requires surgical intervention after complete routine ophthalmological evaluation and evaluation of the angle of strabismus
Exclusion criteria:
Previous strabismus surgery upon the target muscle
Previous orbital surgery, orbital masses, or orbital inflammatory diseases
Age
From 1 year old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
Since it is an operative procedure, only participants will be blinded to the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Committee of the Research Institute of Ophthalmology
Street address
2 El Ahram Street
City
Giza
Postal code
12557
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
571/23-02-2020
Health conditions studied
1
Description of health condition studied
Strabismus
ICD-10 code
H50.9
ICD-10 code description
Unspecified strabismus
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
Ocular motility (freedom vs limitations)
Timepoint
Second day, one week, and one month post-operative
Method of measurement
Assessment of versions and ductions
2
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Surgery
2
Description
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.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Institute of Ophthalmology
Full name of responsible person
Dr. Sameh Galal
Street address
2 El Ahram Street
City
Giza
Postal code
12557
Phone
+20 2 35718304
Email
sameh.galal.1900@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute of Ophthalmology
Full name of responsible person
Dr. Sameh Galal
Street address
2 El Ahram Street
City
Giza
Postal code
12557
Phone
+20 2 35718304
Email
sameh.galal.1900@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self-funded
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Research Institute of Ophthalmology
Full name of responsible person
Dr. Omar Hashem
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
2 El Ahram Street
City
Giza
Province
Cairo
Postal code
12557
Phone
+20 2 35718304
Email
hashemomar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Institute of Ophthalmology
Full name of responsible person
Sameh Galal
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
2 El Ahram Street
City
Giza
Province
Cairo
Postal code
12557
Phone
+20 2 35735688
Fax
Email
sameh.galal.1900@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Research Institute of Ophthalmology
Full name of responsible person
Sameh Galal
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
2 El Ahram Street
City
Giza
Province
Cairo
Postal code
12557
Phone
+20 2 35735688
Fax
Email
sameh.galal.1900@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Extra ocular muscle fenestration IPD set (all collected deidentified IPD)
When the data will become available and for how long
beginning 6 months and ending 36 months following article publication
To whom data/document is available
Researchers from academic institutions whose proposal for the use of data has been approved by an independent review committee identified for this purpose
Under which criteria data/document could be used
for IPD meta-analysis
From where data/document is obtainable
from the PI
What processes are involved for a request to access data/document
A proposal for the use of data to be submitted to the PI, then evaluated by an independent review committee identified for this purpose