| CTRI Number |
CTRI/2024/03/063513 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Central corneal thickness in primary open angle glaucoma and normal tension glaucoma to be compared |
|
Scientific Title of Study
|
“Comparison of central corneal thickness in normal tension glaucoma and primary open angle glaucoma: A cross-sectional 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 Harshita Dubey |
| Designation |
junior resident |
| Affiliation |
Rohilkhand Medical college and hospital |
| Address |
A C girls hostels room number 63 rohilkhand medical college and hospital bareilly department of ophthalmology rohilkhand medical college and hospital bareilly Bareilly UTTAR PRADESH 231217 India |
| Phone |
7080146387 |
| Fax |
|
| Email |
harshita.ncs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashutosh Dokania |
| Designation |
HOD and Professor |
| Affiliation |
rohilkhand medical college and hospital |
| Address |
Residential block Rohilkhand medical college and hospital bareilly Department of ophthalmology rohilkhand medical college and hospital bareilly Bareilly UTTAR PRADESH 243001 India |
| Phone |
9897294857 |
| Fax |
|
| Email |
ashutoshdokania@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashutosh Dokania |
| Designation |
HOD and Professor |
| Affiliation |
rohilkhand medical college and hospital |
| Address |
Resedential block Rohilkhand medical college and hospital bareilly department of ophthalmology rohilkhand medical college and hospital bareilly Bareilly UTTAR PRADESH 243001 India |
| Phone |
9897294857 |
| Fax |
|
| Email |
ashutoshdokania@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ophthalmology room number 1068 |
|
|
Primary Sponsor
|
| Name |
Dr Harshita Dubey |
| Address |
rohilkhand medical college and hospital bareilly UP |
| 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 Harshita Dubey |
rohilkhand medical college and hospital |
department of ophthalmology room number 1068 Bareilly UTTAR PRADESH |
7080146387
harshita.ncs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Rohilkhand Medical College & Hospital Bareilly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have given informed consent.
Patients with Schaffer’s grading 3 to 4 on gonioscopy
Patients who are a case of NTG with IOP<21 mmHg and glaucomatous disc changes .
POAG patients with untreated IOP of >21mmHg with glaucomatous disc changes.
|
|
| ExclusionCriteria |
| Details |
Patients who are not giving consent.
Patients with Schaffer’s grading ≤2 on gonioscopy.
Patients who have corneal pathologies.
Patients of corneal edema due to causes other than glaucoma.
Patients who have undergone previous intraocular surgeries.
Patients diagnosed with secondary glaucoma.
Chronic contact lens wearers.
Patients who have undergone any ocular laser therapy.
Diabetes mellitus.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| central corneal thickness by pachymeter |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| central corneal thickness by pachymeter |
baseline |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
15/03/2024 |
| 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="0" 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
|
It
is by far one of the most significant factors contributing to irreversible
bilateral blindness.¹
There have been efforts to develop screening
techniques for the early diagnosis of the condition since early detection and
treatment may reduce the incidence of visual field loss and subsequent
blindness.²
If glaucomatous optic disc degeneration and field loss
are to be prevented, patients must be properly screened, referred, counselled,
and treated². The differences in central corneal thickness have an impact on
the precision of intraocular pressure measurement using Non-contact tonometry.
The current study compares the central corneal thickness of people with open
angle glaucoma, those with normal tension glaucoma.
Normal-tension glaucoma is a characteristic
glaucomatous optic neuropathy with intraocular pressures in the normal range.³
Primary open angle glaucoma (POAG) is a subset of the glaucomas defined by an
open, normal appearing anterior chamber angle and raised intraocular pressure
(IOP), with no other underlying disease.â´
Measurement
of central corneal thickness is one of the most crucial factor in the
evaluation of any suspected glaucoma patient. is measured using ultrasonic
pachymeter which is based on traditional A-scan ultrasonographyâµ. Normal is
540microns (with a standard deviation of +1 or -1).â¶
A
perimetry, often known as a visual field test, evaluates every aspect of
vision, including the peripheral vision. Loss of peripheral vision is an early
indicator of glaucoma.
Optical
coherence tomography (OCT) is a non-invasive, non-contact imaging technique
that uses infrared light to obtain high-resolution cross-sectional images of
the fundus.â·
This
study aims to evaluate the comparison of central corneal thickness in NTG and
POAG. This study is being undertaken to fill up the research void related to
the comparison of CCT in glaucoma with the help of various modalities. |