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

NCT ID: NCT06913829

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-02-20

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).

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.

Conditions

Convergence Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

base-out exercising prisms

Group Type: EXPERIMENTAL

base-out exercising prisms

Intervention Type: 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.

pencil pushup exercises

Group Type: ACTIVE_COMPARATOR

pencil pushup exercises

Intervention Type: 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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SIGHTON Optix Mozang Chungi

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall23/811

Identifier Type: -

Identifier Source: org_study_id