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Clinical Trials/NCT06913829
NCT06913829Active, not recruitingNot Applicable

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

Superior University1 site in 1 country28 target enrollmentStarted: March 20, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
28
Locations
1
Primary Endpoint
Convergence Insufficiency Symptom Survey

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
10 Years to 50 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

base-out exercising prisms

Experimental

Intervention: base-out exercising prisms (Combination Product)

pencil pushup exercises

Active Comparator

Intervention: pencil pushup exercises (Diagnostic Test)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Muhammad Naveed Babur

Principal Investigator

Superior University

Study Sites (1)

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