| CTRI Number |
CTRI/2024/12/077637 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
RETROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess how certain eye scan markers in a condition called Idiopathic Epiretinal Membrane relate to the patients Vision. |
|
Scientific Title of Study
|
A Retrospective study to find the association between OCT biomarkers of Idiopathic Epiretinal Membrane and Visual Acuity |
| 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 Shailaja S |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Ophthalmology ,Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9686125861 |
| Fax |
|
| Email |
bhatshenoys@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailaja S |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Ophthalmology ,Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9686125861 |
| Fax |
|
| Email |
bhatshenoys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanya Sharma |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Ophthalmology ,Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9411904888 |
| Fax |
|
| Email |
tnsharma99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology, Kasturba Medical College, Madhav Nagar, Manipal, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Department of Ophtalmology Kasturba Medical College Manipal |
| Address |
Department of Ophthalmology, Kasturba Medical College,Manipal, Madhav Nagar, Karnataka,576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Tanya Sharma |
KASTURBA HOSPITAL, MANIPAL |
Room number:26 ,Department of Ophthalmology, Kasturba Hospital, Manipal, Udupi, Karnataka, 576104
Udupi
KARNATAKA |
9411904888
tnsharma99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H35||Other retinal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Presence of Unilateral or Bilateral Epiretinal Membrane whose aetiology cannot be traced back to any disease. |
|
| ExclusionCriteria |
| Details |
1.Epiretinal membrane secondary to any previous ocular surgery, any trauma to the eye, any systemic co-morbidity like Diabetes mellitus leading to Proliferative and Non-proliferative diabetic retinopathy.
2.Any ocular infection or any non -infectious inflammatory condition of the eye.
3.History of Retinal Detachment (traumatic/exudative/rhegmatogenous)
4.Known case of Advanced Glaucoma or Optic Neuropathy
5.Patients diagnosed with any other cause of vision loss other than Epiretinal Membrane
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study aims to bring forth the often ignored parameters that are seen on OCT in patients with Idiopathic Epiretinal membrane and this understanding will help guide the treatment plan of the patients in the future by means of acting as a more reliable indicator of the patient’s visual prognosis. It will also help ascertain the urgency of surgical intervention in the patient |
Assessment of the data of the patient at their first visit, followed by assessment at 3 to 6 months time interval from the first visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analysis of subjects with two sequential OCTs done with a time interval of 3 to 6 months between them, to assess the longitudinal changes in the OCT biomarkers & to determine which Biomarker is associated with worse Visual Acuity. |
Assessment of the data of the patient at their first visit, followed by assessment at 3 to 6 months time interval from the first visit |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
24/12/2024 |
| 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="2"
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
|
Objective: A retrospective study to find an association between the OCT biomarkers of Idiopathic Epiretinal Membrane and the patient’s Visual Acuity. Materials and methods: As per the protocol of treating patients who are diagnosed to have Idiopathic Epiretinal Membrane, an important aspect of managing the disease are follow ups. Patients are called every 6 months for follow ups to the OPD, wherein in each visit their Visual Acuity, OCT and Dilated fundus examination is done so as to assess the progression of the disease and plan intervention accordingly. The study is a Retrospective analysis comparing the OCT biomarkers of patients who have been receiving treatment for Idiopathic Epiretinal membrane with the patient’s visual acuity recorded within a time span of 1 month of their OCT. Medical records of the patients who fulfill the Inclusion criteria will be selected. Data of the visual acuity of the patients will be obtained from the medical records. It will then be converted from Snellen’s format to LOGMAR scale. The analysis of the OCT biomarkers from the medical records will be done by 2 independent observers and compared with the visual acuity |