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CTRI Number  CTRI/2017/11/010504 [Registered on: 15/11/2017] Trial Registered Retrospectively
Last Modified On: 14/11/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Outcome of Transscleral Cyclophotocoagulation which is a laser surgical treatment of glaucoma, a retroscpective study 
Scientific Title of Study   Outcome of Transscleral Cyclophotocoagulation in refractory glaucoma, a retrospective study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neetha KIR 
Designation  Senior Resident 
Affiliation  Nethradhama Superspeciality Eye Hospital  
Address  Nethradhama Superspeciality Eye Hospital 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bengaluru
Nethradhama Superspeciality Eye Hospital 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560082
India 
Phone  9886161979  
Fax  08026633770  
Email  cinnineetha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neetha KIR 
Designation  Senior Resident 
Affiliation  Nethradhama Superspeciality Eye Hospital  
Address  Nethradhama Superspeciality Eye Hospital 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bengaluru
Nethradhama Superspeciality Eye Hospital 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560082
India 
Phone  9886161979  
Fax  08026633770  
Email  cinnineetha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neetha KIR 
Designation  Senior Resident 
Affiliation  Nethradhama Superspeciality Eye Hospital  
Address  Nethradhama Superspeciality Eye Hospital 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bengaluru
Nethradhama Superspeciality Eye Hospital 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bengaluru
Bangalore
KARNATAKA
560082
India 
Phone  9886161979  
Fax  08026633770  
Email  cinnineetha@gmail.com  
 
Source of Monetary or Material Support  
Nethradhama Superspeciality Eye Hospita 
 
Primary Sponsor  
Name  Nethradhama Superspeciality Eye Hospita 
Address  256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore-560 082. 
Type of Sponsor  Private hospital/clinic 
 
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 Neetha KIR   Nethradhama Superspeciality Eye Hospital   256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore-560 082. Bangalore KARNATAKA
Bangalore
KARNATAKA 
9886161979

cinnineetha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nethradhama Superspeciality Eye Hospital Institutional Ethics Committee (IEC)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Glaucoma-Post trans scleral cyclophotocoagulation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  99.00 Day(s)
Gender  Both 
Details  Patients who underwent transscleral cyclophotocoagulation at Nethradhama Superspeciality Eye Hospital 
 
ExclusionCriteria 
Details  Nil 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Post procedure Intra ocular pressure  3 months and/or last visit 
 
Secondary Outcome  
Outcome  TimePoints 
Visual outcome  3 months and/or last visit 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Background:

Transscleral Cyclophotocoagulation (TSCPC) is a cyclodestructive procedure used to control elevated Intra Ocular Pressure (IOP) in refractory glaucoma. Recent literature suggests that cyclophotocoagulation is increasingly performed as the primary surgery for various types and stages of glaucoma, even in patients with good vision.

We set out to analyze efficacy and safety of TSCPC in refractory glaucoma at our hospital.

Methods:

Data was collected retrospectively from patients who underwent TSCPC at our hospital between January 2013 and August 2015. All patients were symptomatic on maximal medical therapy. Primary outcome measure was reduction in IOP and the secondary outcome measures were relief of symptoms and incidence of complications.

Results:

42 patients underwent TSCPC of which 27 were included for analysis. 16men and 11women with mean age 61.81±12.98years and visual acuity ranging from 6/24 to no perception of light were included.

Mean IOP decreased from 46.04±8.6 mmHg (range:26-58 mmHg) pre-procedure to 16.7±13.44 mmHg (p<0.001) at last follow up. Complete success was achieved in 22.2%, qualified success in 18.5%, 29.6% eyes had hypotony and 29.6% failed. Mean glaucoma medications decreased from 3.15±1.30 to 0.89±1.16 (p<0.001). Patients were asymptomatic; complications were phthisis and vitreous hemorrhage which resolved (one case each).

Conclusion: 

Transscleral cyclophotocoagulation is a simple, safe, cost effective method of controlling intra ocular pressures in refractory glaucoma where other methods have high risk of failure. It is repeatable, may not be restricted to eyes with poor vision potential and a symptom free patient is often the end result. 



 
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