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

NCT06913829 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall23/811
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Convergence Insufficiency

Outcome Measures

Primary Outcomes (2)

• Convergence Insufficiency Symptom Survey

  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)

  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

Study Arms (2)

base-out exercising prisms

EXPERIMENTAL

Combination Product: base-out exercising prisms

pencil pushup exercises

ACTIVE COMPARATOR

Diagnostic Test: pencil pushup exercises

Interventions

base-out exercising prisms COMBINATION_PRODUCT

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.

base-out exercising prisms

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.

pencil pushup exercises

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

SIGHTON Optix Mozang Chungi

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases

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: March 29, 2025
• First Posted: April 6, 2025
• Study Start: March 20, 2025
• Primary Completion: June 20, 2025
• Study Completion: February 20, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)