| CTRI Number |
CTRI/2017/06/008765 [Registered on: 06/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Surgical/Anesthesia |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
patients presented to our outpatient clinics with central retinal holes due to trauma were managed by Vitrectomy . To avoid retinal detachment after surgery, we used either Silicon oil or perflouropropane to support the retina in place |
Scientific Title of Study
Modification(s)
|
Pars Plana Vitrectomy with Internal Limiting Membrane Peeling in Traumatic Macular Hole : 14% Perflouropropane versus Silicon Oil Tamponade |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Ashraf Bori |
| Address |
22 elshraei street, zagazig, egypt,
Ophthalmology department, Vitreoretinal consultant Room 5
22486
Other |
| Phone |
00201065338080 |
| Fax |
|
| Email |
ashborai@yahoo.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Ashraf Bori |
| Address |
22 elshraei street, zagazig, egypt
Faculty of medicine Zagazig university, Ophthalmology department Room 5
22486
Other |
| Phone |
00201065338080 |
| Fax |
|
| Email |
ashborai@yahoo.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Wael Elhaig |
| Address |
2 osman ibn affan street, zagazig, egypt
Ophthalmolgy department, faculty of medicine, head of the vitreoretinal unit
22486
Other |
| Phone |
|
| Fax |
|
| Email |
welhaig@hotmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| vitreoretinal unit of ophthalmology department of zagazig university hospital |
|
Primary Sponsor
Modification(s)
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Egypt |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ashraf Bori |
vitroretinal unit of zagazig ophthalmology department |
ophthalmology department of zagazig university hospital, Vitreoretinal unit, Room 5
Not Applicable
|
00201065338080
ashborai@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of zagazig faculty of medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
traumatic macular hole |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Perflouropropane |
Pars plana vitrectomy with internal limiting membrane peeling and C3F8 was injected |
| Intervention |
silicon oil |
Pars plana vitrectomy with internal limiting membrane peeling and silicon injection at the end |
|
Inclusion Criteria
Modification(s)
|
| Age From |
9.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
2 groups |
|
| ExclusionCriteria |
| Details |
those with retinal detachment or vitreous hge |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| disappearance of macular hole and healing |
after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improved vision |
6 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="33"
Sample Size from India="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
No Date Specified |
| Date of First Enrollment (Global) |
25/03/2009 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Not Applicable |
Publication Details
Modification(s)
|
Not yet |
Brief Summary
Modification(s)
|
purpose is to assess safety and efficacy of vitrectomy with internal limiting membrane peeling and tamponade with perflouropropane and silicon oil.
33 eyes were enrolled with 7 eyes close spontaneously
16 eyes received perflouropropane and 10 eyes received silicon oil
Traumatic macular holes can close spontaneously. Both silicon oil and C3F8 are comparable in anatomical and visual outcome
|
