| CTRI Number |
CTRI/2014/05/004614 [Registered on: 22/05/2014] Trial Registered Retrospectively |
| Last Modified On: |
31/01/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Correlation between the damage to structure and function in primary open angle glaucoma. |
|
Scientific Title of Study
|
CORRELATION OF RETINAL NERVE FIBRE LAYER THICKNESS AS MEASURED BY OPTICAL COHERENCE TOMOGRAPHY WITH VISUAL FIELDS BY HUMPHREY FIELD ANALYSER IN EARLY AND MODERATE OPEN – ANGLE GLAUCOMAS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr RAMESH HARIHARAN |
| Designation |
RESIDENT OPHTHALMOLOGIST |
| Affiliation |
VASAN EYE CARE HOSPITAL |
| Address |
No.383, ANNA SALAI, SAIDAPET, CHENNAI, TAMIL NADU, INDIA.
Chennai
TAMIL NADU
600015
India |
| Phone |
9176125740 |
| Fax |
|
| Email |
drrghariharan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr S Venkatesh |
| Designation |
SENIOR CONSULTANT OPHTHALMOLOGIST |
| Affiliation |
VASAN EYE CARE HOSPITAL |
| Address |
No.383, ANNA SALAI, SAIDAPET, CHENNAI, TAMIL NADU, INDIA.
Chennai
TAMIL NADU
600015
India |
| Phone |
9176125740 |
| Fax |
|
| Email |
ophthalm4u@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RAMESH HARIHARAN |
| Designation |
RESIDENT OPHTHALMOLOGIST |
| Affiliation |
VASAN EYE CARE HOSPITAL |
| Address |
No.383, ANNA SALAI, SAIDAPET, CHENNAI, TAMIL NADU, INDIA.
Chennai
TAMIL NADU
600015
India |
| Phone |
9176125740 |
| Fax |
|
| Email |
drrghariharan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VASAN EYE CARE HOSPITAL |
| Address |
No.383, ANNA SALAI, SAIDAPET, CHENNAI, TAMIL NADU. INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| VASAN EYE CARE HOSPITAL |
No.383, ANNA SALAI, SAIDAPET, CHENNAI, TAMIL NADU. INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr RAMESH HARIHARAN |
VASAN EYE CARE HOSPITAL |
Glaucoma Clinic, 2nd Floor, No. 383, ANNA SALAI, SAIDAPET, CHENNAI, TAMIL NADU, INDIA.
Chennai
TAMIL NADU |
9176125740
drrghariharan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VASAN EYE CARE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PRIMARY OPEN ANGLE GLAUCOMA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Humphrey Field Analyzer |
24-2 SITA Standard visual fields (white on white standard achromatic perimetry) |
| Comparator Agent |
Optical Coherence Tomography |
Spectral domain optical coherence tomography with optic nerve and retinal nerve fibre characteristics. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
•Subjects visiting a glaucoma clinic diagnosed with primary open – angle glaucoma.
•Subjects should have best corrected visual acuity not less than 6/18.
•Refractive spherical error within the range of -6.00DS to + 3.00 DS and cylindrical error within +/- 2.5D.
•Visual fields examination of the subjects demonstrating field defects secondary to glaucomatous damage with mean deviation ranging from -2 to -10 decibels (db).
•The visual fields of the subjects should be within the reliability criteria (<20% fixation losses, false positives and false negatives).
•The signal to noise ratio for a reliable OCT – RNFL scan shall not be less than 6.
|
|
| ExclusionCriteria |
| Details |
•History of(H/O) retinal disease or photocoagulation.
•H/O ocular trauma or surgery except an uncomplicated cataract surgery.
•H/O other optic nerve disease except glaucoma
•H/O amblyopia
•Neurological disease which can affect visual fields.
•Visually significant cataracts (Posterior Subcapsular Cataracts, > N.S Grade II). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Structure - function correlation in early and moderate open – angle glaucoma with regards to RNFL thickness and visual field indices. |
At time of presentation over the glaucoma outpatient department |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pattern of visual field loss and retinal nerve fibre layer changes in early and moderate primary open angle glaucoma. |
At time of presentation to the glaucoma outpatient department. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/04/2013 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Glaucoma
is an optic neuropathy characterised by progressive degeneration of retinal
ganglion cells and axons that leads to nerve fibre loss, optic disc cupping,
and consecutive glaucomatous visual field defects. It is considered to be one
of the major causes of blindness worldwide. It
is a well accepted fact least 25 – 40% of retinal ganglion cells need to be
lost before statistically detectable visual field defects appear on automated
visual field testing, which is also consistent with post – mortem histologic
findings in glaucomatous eyes. Since
the damage associated with glaucoma is irreversible, and RNFL loss is
considered as an early sign of glaucomatous damage, its early detection and
prevention is warranted. RNFL studies can be undertaken through non – invasive,
reproducible technologies such as optical coherence tomography, scanning laser
polarimetry etc. The
main purpose of the study is to evaluate the relationship between visual fields
and RNFL thickness as measured by Cirrus spectral domain optical coherence
tomography ((SD – OCT, Carl Zeiss
Meditec Inc. , Dublin, CA.) with visual fields by Humphrey Field Analyser (HFA)
in early and moderate primary open – angle glaucoma. |