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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.⁴

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 ultrasonography⁵. Normal is 540microns (with a standard deviation of +1 or -1).⁶

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.⁷

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.

 
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