| CTRI Number |
CTRI/2024/02/062283 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Sleep Disturbances in Patients of Acute Uveitis and Inflammatory Cystoid Macular Edema |
|
Scientific Title of Study
|
Evaluation of Sleep Related Disturbances in Patients of Acute Uveitis and Inflammatory Cystoid Macular Edema- An Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandita Manjunath |
| Designation |
Primary DNB Resident Doctor |
| Affiliation |
Aravind Eye Hospital |
| Address |
Uvea Clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9920459113 |
| Fax |
|
| Email |
nandita.manjunath98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Bala Murugan |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital |
| Address |
Uvea Clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9360384382 |
| Fax |
|
| Email |
sbalamurugan@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandita Manjunath |
| Designation |
Primary DNB Resident Doctor |
| Affiliation |
Aravind Eye Hospital |
| Address |
Uvea Clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9920459113 |
| Fax |
|
| Email |
nandita.manjunath98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital |
| Address |
Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry |
| 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 Nandita Manjunath |
Aravind Eye Hospital |
Room no 50, Uvea Clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY |
9920459113
nandita.manjunath98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aravind Eye Hospital, Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H200||Acute and subacute iridocyclitis, (2) ICD-10 Condition: H300||Focal chorioretinal inflammation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with acute uveitis.
Patients diagnosed with active inflammatory cystoid macular edema.
|
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed with chronic uveitis.
2. Patient with traumatic uveitis.
3. Patient with post operative uveitis.
4. Patient with diabetic macular edema, diabetic retinopathy.
5. Patients diagnosed with Retinal Vein Occlusions.
6. Patients diagnosed with Retinal Dystrophies.
7. Patients with sleep disorders and under treatment for the same prior to study.
8. Patients with psychiatric illness or on treatment for the same
9. Patients with hearing impairment and speech disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the qualitative and quantitative aspects of sleep disturbances among patients with acute uveitis and inflammatory cystoid macular edema with the Pittsburgh Sleep Quality Index questionnaire at the first visit/baseline and statistically analyze the two for any association. |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the correlation between qualitative & quantitative parameters of sleep using the Pittsburgh Sleep Quality Index questionnaire & qualitative & quantitative OCT findings of inflammatory cystoid macular edema. |
1 year 6 months |
| To conduct a follow up study with Consensus Sleep Diary at next follow up visit. (3 days for acute uveitis & 1 month for inflammatory CME) |
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="191"
Sample Size from India="191"
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)
|
08/02/2024 |
| 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="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
|
· Primary objective: 1. To assess the quality and quantity of sleep disturbances among patients with acute uveitis and inflammatory cystoid macular edema with a standardised validated questionnaire. · Secondary objective: To find out correlation between qualitative/ quantitative parameters of sleep and qualitative / quantitative OCT findings of inflammatory cystoid macular edema.
Hypothesis: Correlation of sleep disturbances in patients with acute uveitis and inflammatory CME can help in unravelling other non-pharmacological methods in tackling uveitis and the associated CME like normalising sleep patterns to help decrease the side effects and dosage of steroids and improve quality of life. It will help in enhancing the understanding of the pathology of uveitis and designing a patient centric approach to the treatment.
|