| CTRI Number |
CTRI/2025/01/079083 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Study on retina detachments in children below 18 years in eye speciality hospital in South India undergoing eye operation |
|
Scientific Title of Study
|
Study of juvenile retinal detachments in tertiary eye care centre in South India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Tejaswini |
| Designation |
Fellow in vitreoretina |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
c/o Srikanchikamakoti Medical Trust
Pedakakni
Guntur district
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9652737353 |
| Fax |
|
| Email |
drtejaswinipagadapelli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu Kumar R |
| Designation |
HOD & Senior Consultant in Vitreoretina Department |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
c/o Srikanchikamakoti Medical Trust
Pedakakni
Guntur district
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9886199899 |
| Fax |
|
| Email |
docmadhu76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Tejaswini |
| Designation |
Fellow in vitreoretina |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
c/o Srikanchikamakoti Medical Trust
Pedakakni
Guntur district
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9652737353 |
| Fax |
|
| Email |
drtejaswinipagadapelli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital
c/o Srikanchikamakoti Medical Trust
Pedakakni
Guntur district
Andhra Pradesh
India 522509 |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hopsital |
| Address |
Sankara Eye Hospital
c/o Srikanchikamakoti Medical Trust
Pedakakni
Guntur district
Andhra Pradesh
India
522509 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 M Tejaswini |
Sankara Eye Hospital |
Dept. of Vitreoretina
Room no.106
c/o Srikanchikamakoti Medical Trust
Pedakakni
Guntur district
Guntur
ANDHRA PRADESH |
9652737353
drtejaswinipagadapelli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHIC COMMITTEE Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H338||Other retinal detachments, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Parsplana vitrectomy |
Patient who need retina detachment surgery are treated with vitrectomy by placing tamponade agents through parsplana route .If gas tamponade , it will get absorbed on its own .If oil tamponade, it will be removed after 1-2 months depending on reattachment of retina |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patient age less than 18 years presenting with any type of retinal detachments are included in the study |
|
| ExclusionCriteria |
| Details |
1) Associated with corneal scarring preventing
fundus visualisation
2) Associated with uveitis
3) Pre existing Glaucoma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To document various parameters like
Age & Gender
Visual acuity at the time of presentation
Etiology of RD
Type of RD |
Time points are baseline Postop 1 day 1 week 1month 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reattachment rates
Post treatment visual acuity improvement
Post surgery complication –cataract, glaucoma
Amblyopia |
1 day , 1 week 1 month , 3 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
To provide contemporary data on the etiology , clinical features and outcomes of pediatric retina detachment.To know various causes for detachemnts in children , their mode of presentation , how differently the pathology in children.To know the recent incidence of pediatric detachments in south india tertiary care centre, becuase most of the previous studies are done longback and are retrospective study. Hence we are carrying prospective studyTo create awarness to the public about the significance of retina detachemts in children.
|