| CTRI Number |
CTRI/2025/03/083469 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of ocular manifestations in cancer patients receiving palliative care |
|
Scientific Title of Study
|
Ocular manifestation in cancer patients receiving palliative care at tertiary care hospital in Coimbatore |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MONISHA A |
| Designation |
MBBS |
| Affiliation |
Kmch institute of health sciences and research |
| Address |
Department of Ophthalmology, A block, 3rd floor, Room no: North 8, Kmch institute of health sciences and research, 99, Civil Aerodrome Avinashi road, Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9361413634 |
| Fax |
|
| Email |
monishaasuvath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Fauzia ara |
| Designation |
MS(OPHTHALMOLOGY) |
| Affiliation |
Kmch institute of health sciences and research |
| Address |
Assistant Professor,Department of Ophthalmology,A block,3rd floor,Room no:North 8, Kmch institute of health sciences and research,99 Civil Aerodrome Avinashi road, Coimbatore.
Coimbatore
TAMIL NADU
641014
India |
| Phone |
8861437062 |
| Fax |
|
| Email |
fauziaara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Fauzia ara |
| Designation |
MS(OPHTHALMOLOGY) |
| Affiliation |
Kmch institute of health sciences and research |
| Address |
Assistant Professor,Department of Ophthalmology,A block,3rd floor,Room no:North 8,Kmch institute of health sciences and research,99 Civil Aerodrome Avinashi road, Coimbatore.
Coimbatore
TAMIL NADU
641014
India |
| Phone |
8861437062 |
| Fax |
|
| Email |
fauziaara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kmch institute of health sciences and research, Coimbatore -641014 |
|
|
Primary Sponsor
|
| Name |
MONISHA A |
| Address |
Kmch institute of health sciences and research, Coimbatore,641014. |
| Type of Sponsor |
Other [Others( 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 Fauzia ara |
Kmch institute of health sciences and research |
Department of Ophthalmology, A block,3 rd floor, Room no: North 8,No:99, Civil Aerodrome , Avinashi road, Coimbatore -641014
Coimbatore
TAMIL NADU |
9361413634
fauziaara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cancer patients undergoing Palliative care. |
|
| ExclusionCriteria |
| Details |
Patients not willing to give consent,
Severe debilitated disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of ocular manifestations in cancer patients undergoing Palliative care is charted |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better treatment methodology is suggested in advance and to improve quality of life of these patients |
6 months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
07/04/2025 |
| 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="0"
Months="6"
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
|
Cancer Patients undergoing Palliative care are usually on various drug regimens to cure the underlying cause. The treatment can contribute to causing ocular problems which may further add to their morbidity. Through this study we aim to assess the Ocular changes in these patients to help guide treatment for these patients in the future and hopefully provide scope to improve their quality of life.
|