| CTRI Number |
CTRI/2024/04/065085 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing IOP and Bleb morphology of Patients who undergo Trabeculectomy with fixed sutures vs releasable sutures in uncontrolled glaucoma |
|
Scientific Title of Study
|
Trabeculectomy surgery with fixed sutures vs Releasable sutures in uncontrolled Glaucoma: Prospective interventional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harika gajjala |
| Designation |
PG junior resident |
| Affiliation |
AIIMS RAIPUR |
| Address |
AIIMS RAIPUR HOSPITAL,Dept of Ophthalmology,Chhattisgarh ,Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
7075851042 |
| Fax |
|
| Email |
harika2k141997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lubna khan |
| Designation |
Associate professor |
| Affiliation |
AIIMS,Raipur |
| Address |
Department of Ophthalmology,AIIMS Raipur, Chattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
7869913118 |
| Fax |
|
| Email |
lubnakhan65@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lubna khan |
| Designation |
Associate professor |
| Affiliation |
AIIMS,Raipur |
| Address |
Department of Ophthalmology, AIIMS Raipur, Chattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
7869913118 |
| Fax |
|
| Email |
lubnakhan65@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Raipur, Chattisgarh, Pincode -492099, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrHarika gajjala |
All India Institute of Medical Sciences |
Department of Ophthalmology
Raipur
CHHATTISGARH |
7075851042
harika2k141997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, (2) ICD-10 Condition: H402||Primary angle-closure glaucoma, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Trabeculectomy surgery with fixed sutures in Uncontrolled Glaucoma |
After the surgery Intraocular pressure and bleb morphology will be compared with Patients who undergo trabeculectomy surgery with Releasable sutures |
| Intervention |
Trabeculectomy surgery with Releasable sutures in Uncontrolled Glaucoma |
Patients with Uncontrolled Glaucoma (both open and closed angle glaucoma) using more than two antiglaucoma medications eventhough Intraocular pressure is not reducing those patients have to undergo trabeculectomy surgery by using Releasable sutures, Intraocular pressure and bleb morphology will be compared with Patients who undergo trabeculectomy surgery with fixed sutures |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with more than or equal two antiglaucoma medications eventhough no change in Intraocular pressure
2.Patients with Open angled glaucoma not responding to drugs
3.Patients with primary angle closure glaucoma not responding to drugs |
|
| ExclusionCriteria |
| Details |
1.Patients with secondary glaucoma due to uveitis, trauma, neovascular and juvenile glaucoma
2.Patients with Phacomorphic glaucoma those who need combined cataract and glaucoma surgery
3.Patients with Phacolytic glaucoma |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trabeculectomies with releasable sutures are expected to give better outcome in terms of IOP reduction and bleb morphology |
Reduction in IOP on Post-OP day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All the Glaucoma patients in ophthalmology department fulfilling inclusion criteria after taking informed consent from the participant.Detailed clinical history of the patients will be taken. Clinical examination of the patients will be done. Visual acuity will be assessed using Snellen’s chart. Ocular examination included Anterior segment evaluation with slit-lamp IOP will be measured by using Goldman applanation tonometry. Humphry’s visual field analysis will be done. Gonioscopy will be done to grade the angle (by using Shaffer’s grading system) and to note the presence and extent of peripheral anterior synechiae. Pupils will be dilated using Tropicamide 0.8%and Phenyalephrine 5% 1 drop every 10 min till full dilatation is achieved. Fundus examination will be done using Indirect ophthalmoscope and90D lens with slit lamp. Follow up visit postoperatively will be on day14 and 28th and at the completion of 3months. Evaluation will include recording of IBAGS bleb score by slit lamp examination, measurement of IOP by GAT.
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