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Clinical Trials/NCT06748534
NCT06748534
Active, not recruiting
Not Applicable

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

Superior University1 site in 1 country38 target enrollmentMarch 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Accommodative Insufficiency
Sponsor
Superior University
Enrollment
38
Locations
1
Primary Endpoint
Monocular and Binocular Accommodative Facility (MAF/BAF)
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
February 28, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Muhammad Naveed Babur

Principal Investigator

Superior University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

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.

Study Sites (1)

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