Convergence InsufficiencyNCT06913829
Efficacy Of Pencil Pushup Exercise Vs Base Out Exercising Prism's In Patient With Convergence Insufficiency
A study testing base-out exercising prisms and pencil pushup exercises in people with Convergence Insufficiency, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Convergence Insufficiency
- What is being tested?
- base-out exercising prisms and pencil pushup exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- base-out exercising prisms, pencil pushup exercises
- Medical subject headings
- Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
base-out exercising prismsCombination 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 exercisesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| base-out exercising prisms | Experimental | Not described Receives: Combination Product: base-out exercising prisms |
| pencil pushup exercises | Active comparator | Not described Receives: Diagnostic Test: pencil pushup exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Convergence InsufficiencyStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913829
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/811
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Pencil Pushup Exercise Vs Base Out Exercising Prism's In Patient With Convergence Insufficiency
- ClinicalTrials.gov ID
- NCT06913829
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/811
- Conditions
- Convergence Insufficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| base-out exercising prisms | Experimental | Combination Product: base-out exercising prisms |
| pencil pushup exercises | Active comparator | Diagnostic Test: pencil pushup exercises |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| base-out exercising prismsParticipants 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. | Combination product | base-out exercising prisms |
| pencil pushup exercisesParticipants 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. | Diagnostic test | pencil pushup exercises |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Convergence Insufficiency
Recruiting
Effectiveness of Osteopathy as an Adjunct to Optometric Vision Therapy in Vergence Disorders
Vergence Disorders, Binocular Vision Dysfunction
Recruiting
Eye Recovery Automation for Post Injury Dysfunction (iRAPID)
Convergence Insufficiency, Traumatic Brain Injury
RecruitingPhase 1
Home-based Vision Therapy
Convergence Insufficiency
RecruitingObservational study
Validation of Clinical Outcome Measures Specific to mTBI-Related Oculomotor Disorders
MTBI - Mild Traumatic Brain Injury
Not yet recruiting
Effect of Oculomotor Therapy in Individuals With Convergence Insufficiency
Convergence Insufficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing base-out exercising prisms and pencil pushup exercises in people with Convergence Insufficiency, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Convergence Insufficiency Symptom Survey (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.