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Single Minimal Conjunctival Incision for Strabismus

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ClinicalTrials.gov Identifier: NCT05987878
Recruitment Status : Completed
First Posted : August 14, 2023
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Jaime Tejedor, Universidad Autonoma de Madrid

Study Description
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Brief Summary:

The purpose of this investigation is to study the feasibility and inflammatory response of surgery for rectus muscles using a small single bulbar conjunctival incision posterior and parallel to the muscle insertion.

Patients requiring surgery of at least one rectus muscle with several diagnoses, operated under general or topical / sub-Tenon's anesthesia, who had no previous eye muscle surgery, will be recruited. Routinary clinical ophthalmological examination will be carried out. After applying a 5-0 PGA traction suture, a 3-4 mm single conjunctival incision posterior and parallel to the rectus muscle insertion will be done. A hang-back recession with 6-0 PGA suture will be carried out, and the conjunctiva closed by an 8-0 PGA single stitch. The main outcome measure will be duration of swelling and hemorrhage, and secondary outcome measure will be motor outcome at 2 months after surgery.


Condition or disease Intervention/treatment
Strabismus, Comitant Procedure: single minimal conjunctival incision

Detailed Description:

Purpose/Background: To study the feasibility and inflammatory response of surgery for rectus muscles using a small single bulbar conjunctival incision posterior and parallel to the muscle insertion.

Methods: Patients requiring surgery of at least one rectus muscle with several diagnoses, operated under general or topical / sub-Tenon's anesthesia, who had no previous eye muscle surgery, are included. Routinary clinical ophthalmological examination is carried out. After applying a 5-0 PGA traction suture, a 3-4 mm single conjunctival incision posterior and parallel to the rectus muscle insertion will be done. A hang-back recession with 6-0 PGA suture will be carried out, and the conjunctiva closed by an 8-0 PGA single stitch. The main outcome measure is duration of swelling and hemorrhage, and secondary outcome measure is motor outcome at 2 months after surgery. Results are compared with retrospectively collected data of patients operated using limbal (n= 20) and fornix incision (n= 21) as a point of reference.

Study Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Single Minimal Conjunctival Incision for Rectus Muscles
Actual Study Start Date : January 31, 2021
Actual Primary Completion Date : March 1, 2023
Actual Study Completion Date : May 1, 2023
Groups and Cohorts
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Intervention Details:
  • Procedure: single minimal conjunctival incision
    A 5-0 PGA traction suture was used near the corneal limbus corresponding to the operated muscle. A 3-4 mm single conjunctival incision posterior and parallel to the insertion in medial, lateral or superior rectus muscle was used. A hang-back recession of the muscle was done using 6-0 PGA suture. The conjunctiva was closed by an 8-0 PGA single stitch with knot burial

Outcome Measures
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Primary Outcome Measures :
  1. Duration of conjunctival swelling/hemorrhage [ Time Frame: 2 months ]
    Evaluate duration of conjunctival swelling/hemorrhage


Secondary Outcome Measures :
  1. Motor outcome at 2 months after surgery (by Prism and Alternate Cover Test) [ Time Frame: 2 months ]
    Evaluate motor status at 2 months after surgery


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
25 subjects who required surgery of rectus muscle in comitant strabismus
Criteria

Inclusion Criteria:

  • patients requiring surgery of at least one rectus muscle with several diagnoses, operated under general or topical / sub-Tenon's anesthesia

Exclusion Criteria:

  • patients had no previous eye muscle surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05987878


Locations
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Spain
UAM
Madrid, Spain, 28029
Sponsors and Collaborators
Universidad Autonoma de Madrid
Investigators
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Principal Investigator: Jaime Tejedor, MD, PhD UAM
More Information
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Responsible Party: Jaime Tejedor, Principal Investigator, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier: NCT05987878    
Other Study ID Numbers: SMCI-22-0213
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data shared when solicited to the PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases