| CTRI Number |
CTRI/2025/03/082854 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Educational Background on Accuracy and Reliability of Vision Testing in Adults |
|
Scientific Title of Study
|
Impact of Patient Educational Level on Performance and Reliability in Humphrey Visual Field Testing |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay Kumar Mishra |
| Designation |
Scientist |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room number 145 Dr R P Centre
All India Institute of Medical Sciences (AIIMS)
New Delhi
Dr R P Centre
All India Institute of Medical Sciences (AIIMS)
New Delhi
South
DELHI
110029
India |
| Phone |
8802105456 |
| Fax |
|
| Email |
sanjaymishraknp@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay Kumar Mishra |
| Designation |
Scientist |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room number 145 Dr R P Centre
All India Institute of Medical Sciences (AIIMS)
New Delhi
Dr R P Centre
All India Institute of Medical Sciences (AIIMS)
New Delhi
South
DELHI
110029
India |
| Phone |
8802105456 |
| Fax |
|
| Email |
sanjaymishraknp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay Kumar Mishra |
| Designation |
Scientist |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room number 145 Dr R P Centre
All India Institute of Medical Sciences (AIIMS)
New Delhi
Dr R P Centre
All India Institute of Medical Sciences (AIIMS)
New Delhi
South
DELHI
110029
India |
| Phone |
8802105456 |
| Fax |
|
| Email |
sanjaymishraknp@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room number 145 Dr R P Centre
All India Institute of Medical Sciences (AIIMS)
New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Room number 145 Dr R P Centre
All India Institute of Medical Sciences (AIIMS)
New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Sanjay Kumar Mishra |
All India Institute of Medical Sciences (AIIMS), Delhi |
Dr. R. P. Centre
All India Institute of Medical Sciences (AIIMS)
New Delhi
South
DELHI |
8802105456
sanjaymishraknp@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institue Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H408||Other glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age: Adults aged 18 years and above.
Clinical Indication: Patients undergoing Humphrey Visual Field (HVF) 24-2 test as part of routine eye care or clinical evaluation for the first time.
Vision Status: Patients with a best-corrected visual acuity (BCVA) of 6/18 (0.48 logMAR) or better in the tested eye.
Educational Background: Patients with varied levels of education, ranging from no formal education to higher education (postgraduate level).
Cognitive and Physical Ability: Patients must be mentally and physically capable of understanding and following HVF test instructions.
Informed Consent: Patients willing to provide written informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Severe Visual Impairment: Best-corrected visual acuity (BCVA) worse than 6/18 (0.48 logMAR) in the tested eye.
Media Opacities: Presence of significant cataract, corneal opacity, or vitreous haze that may interfere with visual field testing.
Neurological Disorders: History of stroke, dementia, or other neurocognitive impairments affecting the ability to perform the test reliably.
Hearing or Communication Impairment: Patients with severe hearing loss or language barriers that prevent understanding of test instructions.
Unstable Fixation: Patients with nystagmus or other ocular motor disorders leading to poor fixation control.
Previous Visual Field Testing Experience: Patients who have undergone HVF testing ever before (to minimize learning effects).
Ocular Conditions Affecting Visual Field: Advanced glaucoma, retinal diseases (e.g., severe diabetic retinopathy, retinal dystrophies), or optic nerve pathologies that could confound test performance.
Medication Use: Patients on CNS-active medications (such as sedatives, antidepressants) that could affect concentration and response time.
Refusal to Participate: Patients unwilling to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reliability and accuracy of Humphrey Visual Field (HVF) test performance based on the participant’s educational level.
o Measured using false positives, false negatives, fixation losses, and mean deviation (MD) values.
o Comparison across different educational levels. |
1. Baseline (prior to HVF test)
2. During the HVF test (real-time assessment)
3. Immediately after the HVF test (post-test evaluation) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Impact of Cognitive & Attention Abilities on HVF Performance
o Assessed using the Trail Making Test (TMT-A & B) & its correlation with HVF test reliability indices.
2. Effect of Visual Acuity on HVF Performance
o Evaluated by comparing Snellen VA (converted to LogMAR) with HVF test parameters. |
1. Baseline (before the HVF test)
2. During the test
3. Immediately after the test as this study does not involve follow-up assessments at later weeks |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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)
|
01/04/2025 |
| 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
|
Title: Impact of Patient Educational Level on Performance and Reliability in Humphrey Visual Field Testing Background: Humphrey Visual Field (HVF) testing is a crucial diagnostic tool for detecting and monitoring glaucoma and other visual field defects. However, patient-related factors such as cognitive ability, attention span, and educational level may influence test performance and reliability. This study aims to evaluate whether a patient’s educational level affects their ability to perform HVF testing accurately and reliably. Study Design: A cross-sectional observational study conducted at AIIMS, New Delhi. Objectives: - Primary Objective: To assess the impact of educational level on reliability indices (false positives, false negatives, fixation losses) and mean deviation (MD), pattern standard deviation (PSD), and testing duration in HVF testing.
- Secondary Objectives: To evaluate the role of cognitive and attention abilities (using the Trail Making Test A & B) and visual acuity (LogMAR conversion) in HVF test performance.
Methodology: - Participants: Adults undergoing HVF testing, categorized based on their highest completed educational level.
- Assessments: Standard Humphrey 24-2 test, cognitive and attention assessment (TMT-A & B), and visual acuity measurement.
- Data Analysis: Comparison of HVF reliability indices across educational groups, correlation analysis with cognitive scores and visual acuity.
Expected Outcome: Identifying the role of education and cognitive function in HVF testing can help refine patient instructions and testing protocols, potentially reducing misdiagnoses due to poor test reliability. |