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NCT Number: NCT06748534

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Accommodative Insufficiency

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dar Ul shifa Eye Trust Hospital & Al Rehman Hospital

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plus Lens Addition (+0.75 D)

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.

Vision Therapy Using HART Chart

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.

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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