| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Glaucoma-Post trans scleral cyclophotocoagulation, |
|
|
Intervention / Comparator Agent
|
|
|
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 |
|
|
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.
|