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CTRI Number  CTRI/2023/08/056128 [Registered on: 04/08/2023] Trial Registered Prospectively
Last Modified On: 19/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Diagnostic
Screening 
Study Design  Other 
Public Title of Study   To compare the success rate of old technique trabeculectomy versus new technique implantation of drainage device in the anterior chamber of the eye in glaucoma patients. 
Scientific Title of Study   A comparative study on clinical outcome of conventional trabeculectomy and glaucoma drainage device in a tertiary health care Centre. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ayushi Tayal 
Designation  Junior Resident 
Affiliation  Jawaharlal nehru medical college sawangi meghe wardha 
Address  Ground floor Department of Ophthalmology Acharya vinoba bhave rural hospital sawangi meghe Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8770457121  
Fax    
Email  ayushi31tayal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sachin Daigavane 
Designation  Professor and HOD 
Affiliation  Jawaharlal nehru medical college sawangi meghe wardha 
Address  Ground floor Department of ophthalmology Acharya vinoba bhave rural hospital sawangi meghe wardha


MAHARASHTRA
442001
India 
Phone  9021736568  
Fax    
Email  drsachin391977@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sachin Daigavane 
Designation  Professor and HOD 
Affiliation  Jawaharlal nehru medical college sawangi meghe wardha 
Address  Ground floor Department of ophthalmology Acharya vinoba bhave rural hospital sawangi meghe wardha


MAHARASHTRA
442001
India 
Phone  9021736568  
Fax    
Email  drsachin391977@gmail.com  
 
Source of Monetary or Material Support  
Acharya vinoba bhave rural hospital datta meghe institute of higher education and research wardha maharashtra 442001 
 
Primary Sponsor  
Name  Jawaharlal nehru medical college SAWANGI 
Address  SAWANGI WARDHA 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR AYUSHI TAYAL  Acharya vinoba bhave rural hospital  Ground floor, Department of ophthalmology Acharya vinoba bhave rural hospital sawangi wardha
Wardha
MAHARASHTRA 		 8770457121

ayushi31tayal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee datta meghe institute of higher education and research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H408||Other glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cross sectional study of 2 years duration  It is 2 years duration study study in which 2 surgical methods will be done In conventional trabeculectomy under local anesthesia A corneal traction suture was placed at the 12 o’clock position and a fornix-based conjunctival flap was created. Blood vessels were cauterized using gentle diathermy. A rectangular half-thickness scleral flap of 4×3 mm was created and a trab of 0.8×2.0 mm was performed followed by a PI. The scleral flap was fixed with single 10.0 nylon sutures placed at both corners of the flap and additional sutures in between if necessary. A 10.0 nylon mattress suture was used to close the conjunctiva at the limbus. In glaucoma drainage device implantation under local anesthesia a fornix based conjunctival flap was taken and tenon’s tissue was then dissected. The site of placement of the implant either supero‑ temporal infero‑nasal was decided by the operating surgeon based on the amount of preexisting conjunctival scarring if any. Adjacent recti muscles in the desired quadrant were isolated using muscle hooks. The AADI implant was then primed to check for any manufacturing defect. The end plate was then positioned between the adjacent recti muscles such that the anterior edge of the plate was around 8 mm from the limbus. The plate was then attached to the underlying sclera with 9-0 Nylon sutures passed through the fixation holes of the implant. A non compressing mattress suture was applied to stabilize the tube to the sclera. Temporary tube occlusion was achieved by ligating it with 6‑0 vicryl suture . Complete closure was then confirmed by attempting to irrigate balanced salt solution through the tube using a 27‑gauge cannula. The scleral fistula was created at about 3 mm from the limbus using a 23‑gauge needle. The tube was then trimmed with an anterior bevel up and inserted into the AC through scleral tract such that it would lie 1–2 mm past the surgical limbus. The position of the tube was confirmed by direct visualization by the operating surgeon. The limbal portion of the tube was covered with partial thickness corneal patch graft. Fenestrations in the tube were made in certain cases, which required short‑term IOP control in immediate postoperative period until the vicryl suture lyses occurs. The conjunctiva and tenon’s capsule were then closed using 8‑0 vicryl sutures using both interrupted and running techniques.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Patients with uncontrolled primary glaucoma.
2)Patients who will be diagnosed with secondary glaucoma.
3)Patients who will be diagnosed with refractory glaucoma.
4)Patients are consenting to study/ giving valid consent.
 
 
ExclusionCriteria 
Details  1)Patients with any ocular infection.
2)Patients having corneal decompensation.
3)Patients with neovascular glaucoma.
4)Patients who did not successfully complete a minimum 1-year follow-up period were not included in this study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Visual acuity testing by Snellen’s chart-
It is used to assess distant visual acuity. The patient is seated 6m away from Snellens chart & is instructed to read the chart with both eyes, one after the other. When the patient can read up to a 6 m line, his visual acuity is reported as 6/6, & depending on the smallest line that the patient can read from a 6 m distance, his vision is recorded as 6/9, 6/12, 6/18, 6/24, 6/36, & 6/60.
2)Intra Ocular Pressure measurement by applanation tonometry-
The Goldmann Applanation Tonometer is commonly recognised as the gold standard in intraocular pressure (IOP) measurement. A topical anaesthetic is instilled into the conjunctival sac, followed by a fluorescein stain. The cobalt blue filter reveals a pattern of two green semicircular mires, with the inner borders of semicircles aligned. The IOP is calculated by multiplying the dial value by ten in mmhg.
 		 2 YEARS 
 
Secondary Outcome  
Outcome  TimePoints 
1)Moorfields bleb grading-
The bleb is assessed & characterized with respect to-
•Diffusion area
•Height
•Vascularity in central, peripheral bleb area and non- bleb area.
2)Need of anti-glaucoma medication-If the post-operative IOP measurement indicates greater values, we will administer anti-glaucoma drugs later.
3)OCT-RNFL and Humphrey visual field analysis
 		 2 YEARS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   15/08/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

 Glaucoma is becoming a more common cause of blindness as the world’s population ages. Glaucoma, the second largest cause of blindness worldwide, accounts approximately 15% of all blindness. It poses an even bigger public health concern than cataracts, however, because the blindness it produces is irreversible.  This study aims to compare the clinical outcomes of traditional trabeculectomy and glaucoma drainage device.  This is a hospital-based study of 30 patients in which we compare clinical results after conventional trabeculectomy and implantation of a glaucoma drainage device. Intraocular pressure measure by Applanation tonometer and best corrected visual acuity testing will be performed in all patients. The data will be compared and statistical analysis will be done.  Patients with Glaucoma drainage implants will have better IOP control.

 
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