| CTRI Number |
CTRI/2023/03/050474 [Registered on: 09/03/2023] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
A prospective, randomized, parallel design study to compare two conjunctival approaches in horizontal strabismus surgery: forniceal versus single snip paralimbal. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Umme Summaiyya |
| Designation |
Junior Resident in MS Ophthalmology |
| Affiliation |
Institute of Ophthalmology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh. |
| Address |
Room number 12,Institute of Ophthalmology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7060796674 |
| Fax |
|
| Email |
summaiyyakhan50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Abadan Khan Amitava |
| Designation |
Professor of strabismology |
| Affiliation |
Institute of Ophthalmology,Jawaharlal Nehru Medical College,AMU |
| Address |
Room number 7, Institute of Ophthalmology, Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7906251522 |
| Fax |
|
| Email |
akamitava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Abadan Khan Amitava |
| Designation |
Professor of strabismology |
| Affiliation |
Institute of Ophthalmology,Jawaharlal Nehru Medical College,AMU |
| Address |
Room number 7, Institute of Ophthalmology, Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7906251522 |
| Fax |
|
| Email |
akamitava@gmail.com |
|
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Source of Monetary or Material Support
|
| Institute of Ophthalmology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh. |
|
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Primary Sponsor
|
| Name |
Umme Summaiyya |
| Address |
Institute of Ophthalmology, Jawaharlal Nehru Medical College , Aligarh Muslim University, Aligarh. |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Umme Summaiyya |
Jawaharlal Nehru Medical College, Aligarh Muslim University, |
Eye OPD number 21 and Strabismus clinic, Institute of Ophthalmology.
Aligarh
UTTAR PRADESH |
7060796674
summaiyyakhan50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jawaharlal Nehru Medical College and Hospital, Faculty of Medicine, Aligarh Muslim University,Aligarh,U.P. India |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 rectus muscle and inferonasal for medial rectus muscle midway between the adjacent rectus muscle insertions; 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, RCNs or RXNs will be done as planned using 6-0 Vicryl double spatulated micropoint suture (braided coated polyglactin 910 violet). After muscle manipulation the conjunctival incision will be closed by using 8-0 Vicryl double spatulated micropoint suture (braided coated polyglactin 910 violet) using 1-2 sutures at the discretion of the surgeon; it may also be left un-sutured if so felt. This is one time proceedure. |
| Comparator Agent |
Single snip paralimbal approach |
Using surgical skin marker, conjunctiva in the quadrant of interest will be marked 2mm away from limbus. The conjunctiva will be pinched up using Pierce-Hoskins conjunctival forceps at the mark and single snip given into the conjunctiva using wescott scissor. The blade of scissor pointing towards muscles of interest,and the cutting vertex abutting the lifted conjunctival flap. This results in V-shaped or crescent shaped conjunctival incision with apex or convexity towards limbus.Arms of the V enclose the muscle insertion which will be exposed by blunt dissection under the conjunctiva and tenons. Rectus muscle recessions or resections will be done as planned using 6-0 vicryl double spatulated micropoint suture (braided coated polyglactin 910 violet). After muscle manipulation the conjunctival incision will be closed using 8-0 vicryl double spatulated micropoint suture( braided coated polyglactin 910 violet) at the apex of V-shaped conjunctival flap. This is one time proceedure. |
|
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Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
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. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
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
|
On the OT table.
eye opening on day1 and at 2 weeks. |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/03/2023 |
| Date of Study Completion (India) |
30/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |