NCT07001124

Brief Summary

The comparative efficacy of the duochrome test versus +1 blur test in detecting refractive errors across different ages remains under-explored in current ophthalmic research. While the duochrome test is widely used to refine prescriptions, its standalone effectiveness compared to +1 blur test based refraction has not been thoroughly investigated.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

May 23, 2025

Last Update Submit

July 12, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Function Index (VF-14) Questionnaire:

    Scores on all activities that the person performed or did not perform because of vision were then averaged, yielding a value from 0 to 4. This value was multiplied by 25, giving a final score from 0 to 100. A score of 100 indicates able to do all applicable activities score of 0 indicates unable to do all applicable activities because of vision

    12 Months

  • +1 blur test

    Adding a +1.00 diopter (DS) lens to a patient's final refraction and measuring their distance visual acuity (VA). There are 4 questions with 5 different options ranging from 0-4. minimum score is 0 and maximum score is 16 with spherical correction.

    12 Months

  • Duochrome Test

    A duochrome test chart .There are 4 questions with 5 different options ranging from 0-4. minimum score is 0 and maximum score is 16 with spherical correction.

    12 Months

Study Arms (2)

duochrome test and +1 blur test (Group1) 18-35

EXPERIMENTAL
Diagnostic Test: duochrome test and +1 blur test

duochrome test and +1 blur test (Group1) 36-60

ACTIVE COMPARATOR
Diagnostic Test: duochrome test and +1 blur test

Interventions

The participant is seated at a standard testing distance (typically 6 meters or 20 feet). A duochrome chart with black letters on a split red-green background is presented. After determining the subjective refraction, a +1.00 diopter (DS) lens is added to the final prescription. The participant is asked to read the distance visual acuity (VA) chart. The expectation is that the visual acuity should drop to 4 lines on Snellen chart (6/24) when the +1.00 DS lens is added. If VA reduces to 6/24: Indicates that the refraction is not over-minused or over-plussed (proper end point of refraction). If VA remains better than 6/24: Suggests the patient was still accommodating, possibly leading to over-minus (in myopes) or under-plus (in hyperopes) and the refraction should be re-evaluated.

duochrome test and +1 blur test (Group1) 18-35duochrome test and +1 blur test (Group1) 36-60

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 to 60 years old.
  • Both genders.
  • Those who have refractive error.
  • Patients with no history of prior eye surgery.
  • No active eye diseases affecting visual acuity, such as cataracts or retinal disorders.
  • Ability to cooperate with both the duochrome test and +1 blur test.

You may not qualify if:

  • Patients with severe visual impairment or neurological conditions affecting vision.
  • Patients with nystagmus or conditions that could interfere with reliable testing.
  • Age below 18 year and above 60 year excluded
  • Those patients who don't show their consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye professionals clinic (14-S DHA Phase 2 Ghazi road)

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 3, 2025

Study Start

March 1, 2025

Primary Completion

August 1, 2025

Study Completion

February 28, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations