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

March 29, 2025 updated by: Muhammad Naveed Babur, Superior University
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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • SIGHTON Optix Mozang Chungi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: base-out exercising prisms
Combination product: base-out exercising prisms

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

  1. 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.

  2. 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.

  3. 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.
Active Comparator: pencil pushup exercises
Diagnostic test: pencil pushup exercises
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2025

Primary Completion (Estimated)

June 20, 2025

Study Completion (Estimated)

February 20, 2026

Study Registration Dates

First Submitted

March 29, 2025

First Submitted That Met QC Criteria

March 29, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

March 29, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSRSW/Batch-Fall23/811

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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