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NCT Number: NCT06913829

Efficacy Of Pencil Pushup Exercise Vs Base Out Exercising Prism's In Patient With Convergence Insufficiency

Convergence insufficiency (CI) is a prevalent binocular vision disorder that leads to symptoms such as eye strain, headaches, and blurred vision during near work. This study aims to evaluate and compare the efficacy of pencil pushup exercises versus base-out exercising prisms in the management of CI. A Randomized Controlled Trial (RCT) will be conducted with 28 participants, using non-probability convenience sampling from SIGHTON Optix, Lahore. Participants will be randomly assigned to either the experimental group (receiving base-out exercising prisms) or the control group (receiving pencil push up exercises). The study will assess symptom improvement using the Convergence Insufficiency Symptom Survey (CISS), near point of convergence (NPC).

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Key information

Conditions

Convergence Insufficiency Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Ocular Motility Disorders

Age range

10 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SIGHTON Optix Mozang Chungi

Lahore, Punjab Province, Pakistan

About this study

The study will also evaluate quality of life (QoL) using a vision-related QoL questionnaire. The total study duration is 3 months, with a primary goal of determining the relative efficacy of these two interventions. This study is expected to provide valuable insights into effective, evidence-based management options for convergence insufficiency, ultimately improving patient outcomes and guiding clinical practice. The collected data will be analysed by using SPSS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients having CISS score more than 16 or higher for children aged <21 and 21 or higher for adults.
  • Patients diagnosed with convergence insufficiency based on clinical tests (e.g., near point of convergence).
  • Age group: 10-50
  • Patients experiencing symptoms related to convergence insufficiency, such as eye strain, headaches, blurred vision, or double vision during near work.
  • Able to perform pencil push-up exercises correctly after demonstration.
  • No other significant ocular or neurological conditions that might affect vision or convergence.

Exclusion criteria

  • Any type of strabismus.
  • Amblyopia.
  • Refractive error more than 6 diopters.
  • Patients with history of prism prescription.
  • History of strabismus surgery or refractive error surgery.
  • History of eye trauma.
  • Any systemic and neurological diseases affecting binocular vision such as diabetes, myasthenia gravis, Graves', and multiple sclerosis.

Treatment and study plan

base-out exercising prisms

Combination Product

Participants in the experimental group will use base-out exercising prisms as their primary intervention. This involves:

  • Procedure:
  • Wearing customized prism glasses designed to increase the convergence demand during near tasks.
  • Performing near vision activities such as reading or viewing objects while wearing the prisms.
  • Schedule:
  • Prisms will be prescribed based on individual clinical measurements.
  • Participants will use the prisms during near tasks for 15-20 minutes daily, 5 days a week, for a total duration of 6 weeks.
  • Monitoring:
  • Initial training will be provided to ensure proper use of the prisms.
  • Adherence will be checked during weekly follow-up visits, where adjustments to the prism strength will be made if necessary.

pencil pushup exercises

Diagnostic Test

Participants in the control group will perform pencil pushup exercises as their primary intervention. This involves: 1. Procedure: o Holding a pencil or similar object vertically at arm's length and focusing on a letter or small mark on it. o Gradually moving the pencil closer to the nose until the participant experiences visual blur or sees double. o Returning the pencil to the starting position and repeating the process. 2. Schedule: o Exercises will be prescribed for 15-20 minutes daily, 5 days a week, for a total duration of 6 weeks. 3. Monitoring: o Participants will receive instructions during the initial session and periodic supervision at follow-up visits to ensure proper technique and adherence. o Progress will be monitored weekly through symptom reporting and clinical measurements.

Primary outcomes

  1. Convergence Insufficiency Symptom Survey

    Time frame: 12 Months

    For Children (< age 21) total score = 16 or higher is suggestive of convergence insufficiency. For Adults total score = 21 or higher is suggestive of convergence insufficiency.

  2. Quality of Life Questionnaire (QOL)

    Time frame: 12 Months

    Scoring Instructions:

    • Each response is scored on a scale from 1 to 5, based on the patient's answer.
    • A higher score indicates a greater negative impact on quality of life.

    Interpretation:

    • Low Scores (10-20): Minimal impact on quality of life.
    • Moderate Scores (21-35): Moderate impact on daily life and well-being.
    • High Scores (36-50): Significant impact on daily activities and quality of life.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

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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