MedDataX Logo

Comparison of Plus Lens Addition Versus Vision Therapy for Management of Accommodative Infacility

NCT ID: NCT06748534

Last Updated: 2024-12-27

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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-02-28

Brief Summary

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

This Randomized Control Trials Study , conducted in Lahore, Pakistan, investigates the comparative efficacy of two approaches-plus lens addition of +0.75 diopters (D) and vision therapy using the HART chart-for managing accommodative infacility. Accommodative infacility, a condition characterized by the eye's reduced ability to adjust focus between distant and near objects, impacts both visual comfort and performance, particularly during prolonged near work.

Detailed Description

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

The study sample comprises 38 participants, aged 15 to 35 years, divided into two groups: one group receiving plus lens addition of +0.75 D and the other undergoing structured vision therapy with the HART chart. Findings revealed that vision therapy was significantly more effective than plus lens addition, with results showing statistical significance at P \< 0.05.

Conditions

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

Accommodative Insufficiency

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

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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

Interventional group I

Group Type EXPERIMENTAL

Plus Lens Addition (+0.75 D)

Intervention Type DIAGNOSTIC_TEST

Participants in this group were provided with +0.75 D lenses, designed to assist in alleviating strain caused by accommodative infacility by reducing the demand on the eye's focusing mechanism.

Interventional group II

Group Type ACTIVE_COMPARATOR

Vision Therapy Using HART Chart

Intervention Type COMBINATION_PRODUCT

Intervention Details: Participants in this group underwent vision therapy sessions utilizing the HART chart, aimed at enhancing their accommodative flexibility through repetitive focusing exercises.

Interventions

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

Plus Lens Addition (+0.75 D)

Participants in this group were provided with +0.75 D lenses, designed to assist in alleviating strain caused by accommodative infacility by reducing the demand on the eye's focusing mechanism.

Intervention Type DIAGNOSTIC_TEST

Vision Therapy Using HART Chart

Intervention Details: Participants in this group underwent vision therapy sessions utilizing the HART chart, aimed at enhancing their accommodative flexibility through repetitive focusing exercises.

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

* Participants aged 15 to 35 years.
* Diagnosed with accommodative infacility.
* Capable of adhering to the full study duration of 6 weeks.
* Measurable accommodative dysfunction confirmed through baseline eye examinations.
* Written informed consent from participants or guardians.

Exclusion Criteria

* Presence of other significant ocular or neurological conditions.
* Inability or unwillingness to adhere to the prescribed treatment.
* Prior treatment for accommodative infacility within the past 6 months.
* Significant uncorrected refractive errors.
* Medical contraindications for using plus lenses or vision therapy.
Minimum Eligible Age

15 Years

Maximum Eligible Age

35 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.

Dar Ul shifa Eye Trust Hospital & Al Rehman Hospital

Lahore, 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-Fall22/763

Identifier Type: -

Identifier Source: org_study_id