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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.

A prospective, randomized, parallel design study to compare two conjunctival approaches in horizontal strabismus surgery: forniceal versus single snip paralimbal.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050474
Enrollment
30
Registered
2023-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Forniceal approach: Eyeball will be rotated away from the field of surgery using fixation forceps at the limbus. The conjunctival incision will be given inferotemporal for lateral rectu
with the incision following the contour of the limbus. Small bit of tenons capsule will be cut and excised. Muscle will be hooked by sweeping the muscle hook on bare sclera
the conjunctiva will be reflected over muscle and tenons and surrounding connective tissue including the check ligaments cleared from the muscles by blunt and sharp dissection. After exposing muscles,
it may also be left un-sutured if so felt. This is one time proceedure. Control Intervention1: Single snip paralimbal approach: Using surgical skin marker, conjunctiva in the quadrant of interest will

Sponsors

Umme Summaiyya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Consenting adults patients with informed consent; and adolescents and children, with their assent, while parents would provide consent. 2. Patients with horizontal (esotropia (ET) or exotropia (XT)) strabismus, qualifying for bilateral symmetrical surgery.

Exclusion criteria

Exclusion criteria: 1. Patients requiring vertical rectus or oblique surgery. 2. Patients with an active ocular inflammatory condition. 3. Patients unable to cooperate due to neurological illness. 4. Patients with recent ocular surgery within 3 months or less.

Design outcomes

Primary

MeasureTime frame
Post-operative inflammation( redness, congestion, chemosis, foreign body sensation and drop intolerance) scored as nil,mild, moderate, severe. Total inflammatory score:an aggregate of the 5 individual clinical inflammatory markers. Surgical success:success being defined as less than 10 PD or orthotropia. Scar visibility from one meter.Timepoint: 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

MeasureTime frame
Duration of surgery in minutes. Lax length of conjunctival incision at the end of suturing. Number of sutures used to close the conjunctival incision. Eye opening Timepoint: On the OT table. eye opening on day1 and at 2 weeks.

Countries

India

Contacts

Public ContactProf Abadan Khan Amitava

Institute of Ophthalmology,Jawaharlal Nehru Medical College,AMU

akamitava@gmail.com7906251522

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026