| CTRI Number |
CTRI/2018/07/014902 [Registered on: 17/07/2018] Trial Registered Prospectively |
| Last Modified On: |
13/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Early Detection of Glaucoma(Human Eye Disease) using Intraocular pressure (IOP), Fundus and Optical coherence tomography (OCT) images of patient
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Scientific Title of Study
|
Automatic detection and analysis of glaucoma disease through Intraocular pressure (IOP), Fundus and Optical coherence tomography (OCT) images. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC 262-2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
suman B R |
| Designation |
Student |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
c/o Prof. Chandrappa S CSE Department SDMIT Ujire Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9743220034 |
| Fax |
|
| Email |
sumanaraghavan1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
chandrappa s |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Mr.Chandrappa S
#B5 B-Block
SDMIT quarters, Ujire, Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9743220034 |
| Fax |
|
| Email |
chandrucs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
suman B R |
| Designation |
Student |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
c/o Prof. Chandrappa S CSE Department SDMIT Ujire Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9743220034 |
| Fax |
|
| Email |
sumanaraghavan1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital Manipal, Karnataka 576104 |
|
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Primary Sponsor
|
| Name |
Kasturba Medical College and Hospital |
| Address |
Kasturba Medical College and Hospital,Manipal, Karnataka 576104 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Suman B R |
Kasturba Medical College & Kasturba Hospital Manipal |
Division: KMC Main Block
Department:Dept of Ophthalmology
Room Number: HOD Chamber
Udupi
KARNATAKA |
9743220034
sumanaraghavan1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with glaucoma disease, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CDR Method |
To calculate the vertical cup to disc ratio (CDR), the optic cup and disc have to be segmented from the retinal images. later, CDR is calculated by using image processing techniques. |
| Comparator Agent |
Gold Standard Values |
Outcomes of proposed approach are evaluated by comparing standard values obtained from the hospital. |
| Intervention |
RNFL thickness |
The OCT RBG images captured by OCT device are used to estimate RNFL thickness. Steps involved in the estimation of RNFL thickness from OCT RBG image using suitable image processing techniques and concepts are first, Pre-process OCT image to remove noises (unwanted pixels present in the image). Second, Enhance the OCT image to increase contract which will help easy edge detection. Later, detect the edges of RNFL present in OCT image and Extract RNFL region using detected edges of RNFL. Finally, Calculate the RNFL thickness using extracted RNFL |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged between 18 to 70 years
2. Data will be collected from the records of patients who have undergone comprehensive eye checkup including IOP, disc photograph and OCT RNFL.
3. No history of eye disease
4. No history of diabetes mellitus
|
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| ExclusionCriteria |
| Details |
1. Aged under 18 or over 70 years
2. Chemical injury eye, infected eye, eye with blocked blood vessels, and eye affected by inflammatory conditions
3. Patients have diabetic retinopathy
|
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Retinal Nerve Fiber Layer Thickness calculated from OCT images using proposed approach is used for early detection of glaucoma |
4 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Cup to Disc ratio calculated from fundus images using proposed approach is used for early detection of glaucoma |
4 months |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/07/2018 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Planned to publish in high-impact factor and peer reviewed journals and also planned to publish research work in conference proceedings. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
purpose and background of trial: Glaucoma is a multi-factorial optic neuropathy characterised by progressive structural loss of retinal ganglion cells (RGC) that may result in vision loss and irreversible blindness. The ability to detect structural loss is fundamental in the diagnosis and management of glaucoma. While glaucomatous structural damage can be assessed subjectively by clinically examining the optic nerve head (ONH),IOP and peripapillary retinal nerve fibre layer (RNFL), the introduction of ocular imaging modalities into clinical management has allowed for supplemental objective and quantitative evaluation of ocular structure.so, this study is helpful for analysis of glaucoma disease in the initial stage. findings of study: - A approach to measure the thickness of retinal nerve fiber layer from OCT images
- Aapproach to extract cup and disc areas from fundus images and calculate the cup to disc ratio.
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