Impact of Positive & Negative Lens-Induced Defocus on Contrast-Sensitivity in Myopic & Non-Myopic Adults

NCT ID: NCT06753032

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-28

Study Completion Date

2025-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

examines the influence of lens-induced defocus on contrast sensitivity-a crucial aspect of visual performance.Each participant experiences both positive and negative defocus through different lenses, with measurements taken for contrast sensitivity using the Pelli-Robson chart. Outcomes are evaluated at baseline, 2 weeks, and 4 weeks to understand the effect of defocus over time.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Additional data on symptoms like visual fatigue and computer vision syndrome are gathered using the Visual Fatigue Questionnaire (VFQ) and the Computer Vision Syndrome Questionnaire (CVS-Q), respectively. This study's findings could be instrumental in refining optical treatments, offering insights into how defocus impacts visual function across refractive conditions. Results may ultimately benefit optometric practices by guiding lens prescriptions for improved contrast sensitivity and quality of life for myopic and non-myopic individuals alike.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

interventional group

Group Type EXPERIMENTAL

Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Myopic Participants

Intervention Type DIAGNOSTIC_TEST

Intervention Description: This group will be exposed to positive defocus induced by +2.00 D spectacle lenses. The lenses are designed to create optical blur to evaluate the effects on contrast sensitivity and visual fatigue. Measurements will be conducted at baseline, 2 weeks, and 4 weeks after exposure to assess changes in visual function."

Interventional group II

Group Type EXPERIMENTAL

Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Myopic Participants

Intervention Type DIAGNOSTIC_TEST

Intervention Description: This group will be exposed to negative defocus induced by -2.00 D spectacle lenses. The induced defocus will allow for the evaluation of its impact on contrast sensitivity and visual fatigue. Assessments will be carried out at baseline, 2 weeks, and 4 weeks."

Interventional group III

Group Type ACTIVE_COMPARATOR

Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Non-Myopic Participants

Intervention Type COMBINATION_PRODUCT

ntervention Description: This group will undergo positive defocus using +2.00 D spectacle lenses. The intervention aims to examine the effect of induced defocus on contrast sensitivity and visual fatigue in non-myopic participants. Data will be collected at baseline, 2 weeks, and 4 weeks."

Interventional group IV

Group Type ACTIVE_COMPARATOR

Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Non-Myopic Participants

Intervention Type COMBINATION_PRODUCT

Intervention Description: This group will experience negative defocus induced by -2.00 D spectacle lenses. The purpose is to evaluate how negative lens-induced defocus affects contrast sensitivity and visual fatigue in non-myopic participants. Measurements will be taken at baseline, 2 weeks, and 4 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Myopic Participants

Intervention Description: This group will be exposed to positive defocus induced by +2.00 D spectacle lenses. The lenses are designed to create optical blur to evaluate the effects on contrast sensitivity and visual fatigue. Measurements will be conducted at baseline, 2 weeks, and 4 weeks after exposure to assess changes in visual function."

Intervention Type DIAGNOSTIC_TEST

Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Myopic Participants

Intervention Description: This group will be exposed to negative defocus induced by -2.00 D spectacle lenses. The induced defocus will allow for the evaluation of its impact on contrast sensitivity and visual fatigue. Assessments will be carried out at baseline, 2 weeks, and 4 weeks."

Intervention Type DIAGNOSTIC_TEST

Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Non-Myopic Participants

ntervention Description: This group will undergo positive defocus using +2.00 D spectacle lenses. The intervention aims to examine the effect of induced defocus on contrast sensitivity and visual fatigue in non-myopic participants. Data will be collected at baseline, 2 weeks, and 4 weeks."

Intervention Type COMBINATION_PRODUCT

Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Non-Myopic Participants

Intervention Description: This group will experience negative defocus induced by -2.00 D spectacle lenses. The purpose is to evaluate how negative lens-induced defocus affects contrast sensitivity and visual fatigue in non-myopic participants. Measurements will be taken at baseline, 2 weeks, and 4 weeks.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults aged 18 to 50 years.
* Participants with a confirmed diagnosis of myopia or non-myopia.
* Best corrected visual acuity of 20/30 or better.
* No history of ocular surgery or significant ocular disease.
* Informed consent was obtained.

Exclusion Criteria

* Individuals with a history of systemic diseases affecting vision (e.g., diabetes, hypertension).
* Presence of binocular vision anomalies or strabismus.
* Pregnant or nursing women.
* Any current use of medications affecting visual function (e.g., medications causing visual side effects).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Superior University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Muhammad Naveed Babur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tehsil Headquarters (THQ)

Taunsa, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MSRSW/Batch-Fall22/750

Identifier Type: -

Identifier Source: org_study_id