A study to compare two conjunctival approaches:forniceal versus single snip paralimbal in each pateint scheduled for bilateral symmetrical horizontal strabismus surgery, randomizing one eye to either a forniceal approach or a paralimbal approach.

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/03/050474
• Lead Sponsor: Umme Summaiyya

Brief Summary

To compare the post-operative inflammation (redness, congestion, chemosis, foreign body sensation and drop intolerance) on day1, at 2 weeks +\_ 2-3days and 4-6weeks, scar visibility and success rate at 4-6weeks in cases of horizontal strabismus surgery randomized to two conjunctival approaches: forniceal versus single snip paralimbal. In addition to compare time taken to do surgery, lax length of conjunctiva at the end od suturing and number of sutures used to close conjunctival incision. Patient will be asked which of his/her eye feels more comfortable: right eye, left eye, or cannot say. This will be done post-operatively on day 1 and week 2.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-03
• Study Completion: 2024-06-30
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Consenting adults patients with informed consent; and adolescents and children, with their assent, while parents would provide consent.
• Patients with horizontal (esotropia (ET) or exotropia (XT)) strabismus, qualifying for bilateral symmetrical surgery.

Exclusion Criteria

• Patients requiring vertical rectus or oblique surgery.
• Patients unable to cooperate due to neurological illness.
• Patients with recent ocular surgery within 3 months or less.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total inflammatory score:an aggregate of the 5 individual clinical inflammatory markers.	Post-operative inflammation( redness, congestion, chemosis, foreign body sensation and drop intolerance) on post-operative day 1, at 2weeks and at 4-6weeks. | Total inflammatory score on post-operative day 1, at 2weeks and at 4-6weeks. | Surgical success at post-operative 4-6 weeks. | Scar visibility at post-operative 4-6 weeks.
Post-operative inflammation( redness, congestion, chemosis, foreign body sensation and drop intolerance) scored as nil,mild, moderate, severe.	Post-operative inflammation( redness, congestion, chemosis, foreign body sensation and drop intolerance) on post-operative day 1, at 2weeks and at 4-6weeks. | Total inflammatory score on post-operative day 1, at 2weeks and at 4-6weeks. | Surgical success at post-operative 4-6 weeks. | Scar visibility at post-operative 4-6 weeks.
Surgical success:success being defined as less than 10 PD or orthotropia.	Post-operative inflammation( redness, congestion, chemosis, foreign body sensation and drop intolerance) on post-operative day 1, at 2weeks and at 4-6weeks. | Total inflammatory score on post-operative day 1, at 2weeks and at 4-6weeks. | Surgical success at post-operative 4-6 weeks. | Scar visibility at post-operative 4-6 weeks.
Scar visibility from one meter.	Post-operative inflammation( redness, congestion, chemosis, foreign body sensation and drop intolerance) on post-operative day 1, at 2weeks and at 4-6weeks. | Total inflammatory score on post-operative day 1, at 2weeks and at 4-6weeks. | Surgical success at post-operative 4-6 weeks. | Scar visibility at post-operative 4-6 weeks.

Secondary Outcome Measures

Name	Time	Method
Duration of surgery in minutes.	Lax length of conjunctival incision at the end of suturing.

Trial Locations

Locations (1)

Jawaharlal Nehru Medical College, Aligarh Muslim University,; 🇮🇳 Aligarh, UTTAR PRADESH, India

Jawaharlal Nehru Medical College, Aligarh Muslim University,

🇮🇳Aligarh, UTTAR PRADESH, India

Umme Summaiyya

Principal investigator

7060796674

summaiyyakhan50@gmail.com