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

December 22, 2024 updated by: Muhammad Naveed Babur, Superior University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Dar Ul shifa Eye Trust Hospital & Al Rehman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional group I
Diagnostic test: 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.
Active Comparator: Interventional group II
Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monocular and Binocular Accommodative Facility (MAF/BAF)
Time Frame: 12 Months
Improvement in accommodative facility measured using Monocular and Binocular Accommodative Facility (MAF/BAF) tests with ±2.00 D flipper lenses. Measurement is recorded in cycles per minute (cpm).
12 Months
subjective measures of visual comfort
Time Frame: 12 Months
Reduction in symptoms of accommodative infacility assessed using a customized performa. Measurement is based on a symptom severity score recorded pre- and post-intervention.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

December 14, 2024

First Submitted That Met QC Criteria

December 22, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 22, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MSRSW/Batch-Fall22/763

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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