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

NCT06748534 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/763
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Accommodative Insufficiency

Outcome Measures

Primary Outcomes (2)

• Monocular and Binocular Accommodative Facility (MAF/BAF)

  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

  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

Study Arms (2)

Interventional group I

EXPERIMENTAL

Diagnostic Test: Plus Lens Addition (+0.75 D)

Interventional group II

ACTIVE COMPARATOR

Combination Product: Vision Therapy Using HART Chart

Interventions

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.

Interventional group I

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.

Interventional group II

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Dar Ul shifa Eye Trust Hospital & Al Rehman Hospital

Lahore, Punjab Province, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 27, 2024
• Study Start: March 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: February 28, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)