| CTRI Number |
CTRI/2023/03/051211 [Registered on: 31/03/2023] Trial Registered Prospectively |
| Last Modified On: |
29/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Counselling Method] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Video versus Verbal Counselling for Various Oculoplastic Procedures |
|
Scientific Title of Study
|
Randomized Control Trial of Video versus Verbal Counselling for Various Oculoplastic Procedures - With Addition of ‘Teach-back’ Method |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishant V Maindargi |
| Designation |
Primary DNB |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Room No:13, Orbit Clinic, Aravind Eye Hospital, Cuddalore Main
Road, Thavalakuppam, Pondicherry
605007
Aravind Eye Hospital, Cuddalore main road, Thavalakuppam, Pondicherry. 605007
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9011334646 |
| Fax |
|
| Email |
nishant.vivekanand@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Jayagayathri |
| Designation |
Chief, Orbit and Oculoplasty Unit |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Room No:13, Orbit Clinic, Aravind Eye Hospital, Cuddalore Main
Road, Thavalakuppam, Pondicherry
605007
Aravind Eye Hospital, Cuddalore Main
Road, Thavalakuppam, Pondicherry
605007
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9843942425 |
| Fax |
|
| Email |
jayagayathri.dr@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishant V Maindargi |
| Designation |
Primary DNB |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Room No:13, Orbit Clinic, Aravind Eye Hospital, Cuddalore Main
Road, Thavalakuppam, Pondicherry
605007
Aravind Eye Hospital, Cuddalore Main
Road, Thavalakuppam, Pondicherry
605007
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9011334646 |
| Fax |
|
| Email |
nishant.vivekanand@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Dr Nishant Maindargi |
| Address |
Aravind Eye Hospital, Pondicherry. 605007 |
| Type of Sponsor |
Other [self] |
|
|
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 Nishant Maindargi |
Orbit and Oculoplasty Unit |
Orbit and Oculoplasty Unity,
Room number 13,
Aravind Eye Hospital, Cuddalore Main Road, Pondicherry. 605007
Pondicherry
PONDICHERRY |
9011334646
nishant.vivekanand@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Aravind Eye Hospital, Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H044||Chronic inflammation of lacrimal passages, (2) ICD-10 Condition: H021||Ectropion of eyelid, (3) ICD-10 Condition: H020||Entropion and trichiasis of eyelid, (4) ICD-10 Condition: H024||Ptosis of eyelid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Intervention |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patients diagnosed with ptosis, entropion, ectropion and dacryocystitis at Aravind Eye Hospital, Pondicherry and yet to undergo surgery.
(2) Patient of above 18 years of age who are able to give informed consent and willing to participate in the study.
(3) Parent/s of minor patient who can give informed consent and willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
(1) Patients requiring emergency-basis treatment.
(2) Pregnant women
(3) Children who are not accompanied by parents
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acceptance rate of oculoplasty procedures among patient undergoing video versus verbal counseling methods |
365 days |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
31/03/2023 |
| 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
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomized Control Trial Study to compare the effect of video counselling and verbal counselling on patient’s knowledge about various oculoplastic diseases viz - Ptosis, entropion, ectropion, chronic dacryocystitis, and their treatment to find out which counselling method is effective in terms of treatment acceptance. |