| CTRI Number |
CTRI/2023/03/051050 [Registered on: 24/03/2023] Trial Registered Prospectively |
| Last Modified On: |
23/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
Measurement and Analysis of thickness of different parts of retina in people with nearsightedness, farsightedness and normal vision |
|
Scientific Title of Study
|
Central Macular, Ganglion cell Complex (GCC) and Peripapillary nerve fiber layer thickness (NFL) in patients with Myopia, Hyperopia and Emmetropia-A Optical Coherence Tomography Study (OCT) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya Mishra |
| Designation |
Junior Resident |
| Affiliation |
Dept of Ophthalmology, KMC Manipal |
| Address |
Dept of Ophthalmology, second floor, OPD Block, KMC Manipal, MAHE
Udupi
KARNATAKA
737104
India |
| Phone |
7652096317 |
| Fax |
|
| Email |
aishwaryamishr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaya Pai H |
| Designation |
PROFESSOR AND HOU |
| Affiliation |
Dept of Ophthalmology, KMC Manipal |
| Address |
DEPT OF OPHTHALMOLOGY, 2ND FLOOR, KMC MANIPAL, MAHE
Udupi
KARNATAKA
737104
India |
| Phone |
|
| Fax |
|
| Email |
PAI.VIJAYA@MANIPAL.EDU |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Mishra |
| Designation |
Junior Resident |
| Affiliation |
Dept of Ophthalmology, KMC Manipal |
| Address |
Dept of Ophthalmology, second floor, OPD Block, KMC Manipal, MAHE
Udupi
KARNATAKA
737104
India |
| Phone |
7652096317 |
| Fax |
|
| Email |
aishwaryamishr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka |
|
|
Primary Sponsor
|
| Name |
DR AISHWARYA MISHRA |
| Address |
ROOM NO 1131, NIH A BLOCK, MAHE, MANIPAL |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DR AISHWARYA MISHRA |
KASTURBA MANIPAL HOSPITAL, MANIPAL |
DEPT OF OPHTHALMOLOGY, SECOND FLOOR, OPD BLOCK, KMC MANIPAL, MAHE
Udupi
KARNATAKA |
8348013264
aishwaryamishr@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-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, (2) ICD-10 Condition: H520||Hypermetropia, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Myopes (<−12.0 D),
Emmetropes
Hyperopes (<+5 D)
|
|
| ExclusionCriteria |
| Details |
Patients not consenting for the study
Ocular diseases like glaucoma, hypertensive retinopathy, diabetic retinopathy and optic neuropathy
Age <18 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Central Macular thickness, Ganglion cell complex thickness and Retinal nerve fiber layer thickness will be measured |
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison between Myopia, Hyperopia and Emmetropia |
End of sample collection with baseline values |
|
|
Target Sample Size
|
Total Sample Size="213"
Sample Size from India="213"
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)
|
04/04/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Optical Coherence tomography (OCT) is noninvasive, non-contact method of cross-section imaging technology. It allows detection, assessment and measurement of various retinal diseases. It was first introduced in 1991 and by 2000s it was widely used in ophthalmology to detect diseases like glaucoma and retinal diseases. Refractive error is associated with changes in Retinal Thickness. These changes are more extensively studied in myopic. Kang S and Hong S reported on thinning of superior and inferior RNFL in myopia and peak RNFL thickness temporally [1]. Lu B and Wang Y found GCC fiber thickest superonasally and thinnest inferiorly in young myopic Chinese adults [2]. Zhao M et al concluded that central macular thickness in myopic maximum in central foveal region and minimum in inner and outer region expect inner superior and nasal region. It was consisted with anatomy of nerve fiber, more crowded in inner region and relatively dispersed in outer region [3]. TaÅŸ M et al inferred thicker RNFL in superior and nasal quadrant of high hyperopic children [4] and no other much study has been done in adults, hence the understanding of RNFL, GCC and central macular thickness in hyperopic is limited. Lee JWY et al found that global thinning of RNFL in myopic children as compared to emmetropes and hyperopes [5]. And another study by Yau GSK and Lee JWY reported central macular thickness in myopic were significantly thicker than other emmetropic and hyperopic group of children [6]. They also agreed to postulation that this difference in macular thickness mainly due to compensatory response to thinner peripheral fibers in myopic to maintain fovea. Last two studies are only studies that compared three refractive groups with retinal thickness. But both of these studies were done in Chinese children, no similar studies have been done in adults |