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

Not Applicable

Active, not recruiting

• Conditions: Accommodative Insufficiency

• Registration Number: NCT06748534
• Lead Sponsor: Superior University

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.

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-08-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-14
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Monocular and Binocular Accommodative Facility (MAF/BAF)	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	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.

Trial Locations

Locations (1)

Dar Ul shifa Eye Trust Hospital & Al Rehman Hospital; 🇵🇰 Lahore, Punjab, Pakistan