Single Minimal Conjunctival Incision for Strabismus

Sponsor
Universidad Autonoma de Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT05987878
Collaborator
(none)
25
1
26.9
0.9

Study Details

Study Description

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 Phase
  • 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

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 :
Jan 31, 2021
Actual Primary Completion Date :
Mar 1, 2023
Actual Study Completion Date :
May 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Duration of conjunctival swelling/hemorrhage [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) [2 months]

    Evaluate motor status at 2 months after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 60 Years
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 UAM Madrid Spain 28029

Sponsors and Collaborators

  • Universidad Autonoma de Madrid

Investigators

  • Principal Investigator: Jaime Tejedor, MD, PhD, UAM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jaime Tejedor, Principal Investigator, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier:
NCT05987878
Other Study ID Numbers:
  • SMCI-22-0213
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023