| CTRI Number |
CTRI/2019/02/017525 [Registered on: 07/02/2019] Trial Registered Prospectively |
| Last Modified On: |
04/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
New surgical treatment of Glaucoma trial |
|
Scientific Title of Study
|
A prospective trial to assess results of trabeculectomy by using ologen as continuum from sub-scleral space to sub-conjunctival space |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRoop |
| Designation |
Medical Director |
| Affiliation |
Centre for Sight |
| Address |
Centre for Sight
Roop Netralaya
Opp NAS College
E K Road
Meerut
Meerut
UTTAR PRADESH
250001
India |
| Phone |
9897077115 |
| Fax |
|
| Email |
roopfamous@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRoop |
| Designation |
Medical Director |
| Affiliation |
Centre for Sight |
| Address |
Centre for Sight
Roop Netralaya
Opp NAS College
E K Road
Meerut
Meerut
UTTAR PRADESH
250001
India |
| Phone |
9897077115 |
| Fax |
|
| Email |
roopfamous@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRoop |
| Designation |
Medical Director |
| Affiliation |
Centre for Sight |
| Address |
Centre for Sight
Roop Netralaya
Opp NAS College
E K Road
Meerut
Meerut
UTTAR PRADESH
250001
India |
| Phone |
9897077115 |
| Fax |
|
| Email |
roopfamous@gmail.com |
|
|
Source of Monetary or Material Support
|
| CFS Netralaya Pvt Ltd
Roop Netralaya
E K Road
Meerut |
|
|
Primary Sponsor
|
| Name |
Centre for Sight |
| Address |
Centre for Sight
Roop Netralaya
Opp NAS College
E K Road
Meerut |
| 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 Roop |
Centre for Sight |
MD Room, 1st Floor
Glaucoma Unit
Meerut
UTTAR PRADESH |
9897077115
roopfamous@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Centre for sight institutional medical ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H409||Unspecified glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glaucoma surgery |
Using Ologen as continuum from subscleral space to subconjuctival space during trabeculectomy. Results are evaluated for 3 months after surgery. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients with IOP not controlled on medication
b) Patients willing to undergo trab as an alternative to life-long medication
c) Patients not tolerating the anti-glaucoma medication
|
|
| ExclusionCriteria |
| Details |
a) Any co-morbidity which contra-indicates surgery
b) Patients having neo-vascular glaucoma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of subjects having IOP of less than 20 mm Hg without or with reduced medication after 3months of surgery. |
Percentage of subjects having IOP of less than 20 mm Hg without or with reduced medication after 3months of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse event |
Day 1,3, 10, 30, 90 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/02/2019 |
| Date of Study Completion (India) |
03/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Glaucome is the leading cause of blindness in India. Trabeculectomy is the only permanent solution to this problem. In the past anti-metabolites and Ologen have been used to enhance the success of trabeculectomy. But till now Ologen is placed over the scleral flap. This placement does not help in preventing fifbosis of scleral tunnel. In the present study patients suffering from glaucoma satisfying inclusion criteria, will be operated for trabeculectomy. Ologen will be used as continuum from sub-scleral space to sub-conjunctival space. Reduction in IOP to less than 20mm of Hg with no or reduced medication will be qualified as success. Any adverse event will be recorded. Results Average preop medication used was 2.9, which was reduced to 0.05 post intervention. Average preop IOP was 30mm of Hg on treatment which reduced to 14mm of Hg. Two patients had hypotony in post op period which resolved without any intervention. One patient had spontaneous migration of ologen out from ostium into sub-tenon space without any adverse effect. Conclusion Using Ologen in continuum from anterior chamber to sub-tenon space is an effective and safe technique for improving results of trabeculectomy. |