Accommodative InsufficiencyNCT06748534
Comparison of Plus Lens Addition Versus Vision Therapy for Management of Accommodative Infacility
A study testing Plus Lens Addition (+0.75 D) and Vision Therapy Using HART Chart in people with Accommodative Insufficiency, run by Superior University at 1 site in Pakistan.
Trial summary
This Randomized Control Trials Study , conducted in Lahore, Pakistan, investigates the comparative efficacy of two approaches-plus lens addition of +0.75 diopters (D) and vision therapy using the HART chart-for managing accommodative infacility. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Accommodative Insufficiency
- What is being tested?
- Plus Lens Addition (+0.75 D) and Vision Therapy Using HART Chart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 28 Feb 2025
- 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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants aged 15 to 35 years.
- Diagnosed with accommodative infacility.
- Capable of adhering to the full study duration of 6 weeks.
- Measurable accommodative dysfunction confirmed through baseline eye examinations.
- Written informed consent from participants or guardians.
Who cannot join
- Presence of other significant ocular or neurological conditions.
- Inability or unwillingness to adhere to the prescribed treatment.
- Prior treatment for accommodative infacility within the past 6 months.
- Significant uncorrected refractive errors.
- Medical contraindications for using plus lenses or vision therapy.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dar Ul shifa Eye Trust Hospital & Al Rehman Hospital
Lahore, Punjab Province
About this study
This Randomized Control Trials Study , conducted in Lahore, Pakistan, investigates the comparative efficacy of two approaches-plus lens addition of +0.75 diopters (D) and vision therapy using the HART chart-for managing accommodative infacility. Accommodative infacility, a condition characterized by the eye's reduced ability to adjust focus between distant and near objects, impacts both visual comfort and performance, particularly during prolonged near work.
Read the detailed description
The study sample comprises 38 participants, aged 15 to 35 years, divided into two groups: one group receiving plus lens addition of +0.75 D and the other undergoing structured vision therapy with the HART chart. Findings revealed that vision therapy was significantly more effective than plus lens addition, with results showing statistical significance at P < 0.05.
- Conditions
- Accommodative Insufficiency
- Being tested
- Plus Lens Addition (+0.75 D), Vision Therapy Using HART Chart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plus Lens Addition (+0.75 D)Diagnostic test
Participants in this group were provided with +0.75 D lenses, designed to assist in alleviating strain caused by accommodative infacility by reducing the demand on the eye's focusing mechanism.
Vision Therapy Using HART ChartCombination product
Intervention Details: Participants in this group underwent vision therapy sessions utilizing the HART chart, aimed at enhancing their accommodative flexibility through repetitive focusing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group I | Experimental | Not described Receives: Diagnostic Test: Plus Lens Addition (+0.75 D) |
| Interventional group II | Active comparator | Not described Receives: Combination Product: Vision Therapy Using HART Chart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular and Binocular Accommodative Facility (MAF/BAF)
Improvement in accommodative facility measured using Monocular and Binocular Accommodative Facility (MAF/BAF) tests with ±2.00 D flipper lenses. Measurement is recorded in cycles per minute (cpm).
Measured: 12 Months
subjective measures of visual comfort
Reduction in symptoms of accommodative infacility assessed using a customized performa. Measurement is based on a symptom severity score recorded pre- and post-intervention.
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 posted27 Dec 2024
- Study start1 Mar 2024
- Primary completion1 Aug 2024
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accommodative 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
- 38 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
- NCT06748534
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/763
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2024
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plus Lens Addition Versus Vision Therapy for Management of Accommodative Infacility
- ClinicalTrials.gov ID
- NCT06748534
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/763
- Conditions
- Accommodative Insufficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 27 Dec 2024 (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.
This Randomized Control Trials Study , conducted in Lahore, Pakistan, investigates the comparative efficacy of two approaches-plus lens addition of +0.75 diopters (D) and vision therapy using the HART chart-for managing accommodative infacility. Accommodative infacility, a condition characterized by the eye's reduced ability to adjust focus between distant and near objects, impacts both visual comfort and performance, particularly during prolonged near work.
Detailed description
The study sample comprises 38 participants, aged 15 to 35 years, divided into two groups: one group receiving plus lens addition of +0.75 D and the other undergoing structured vision therapy with the HART chart. Findings revealed that vision therapy was significantly more effective than plus lens addition, with results showing statistical significance at P < 0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group I | Experimental | Diagnostic Test: Plus Lens Addition (+0.75 D) |
| Interventional group II | Active comparator | Combination Product: Vision Therapy Using HART Chart |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Participants aged 15 to 35 years.
- Diagnosed with accommodative infacility.
- Capable of adhering to the full study duration of 6 weeks.
- Measurable accommodative dysfunction confirmed through baseline eye examinations.
- Written informed consent from participants or guardians.
Key exclusion criteria (5 listed)
- Presence of other significant ocular or neurological conditions.
- Inability or unwillingness to adhere to the prescribed treatment.
- Prior treatment for accommodative infacility within the past 6 months.
- Significant uncorrected refractive errors.
- Medical contraindications for using plus lenses or vision therapy.
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 |
|---|---|---|
| Plus Lens Addition (+0.75 D)Participants in this group were provided with +0.75 D lenses, designed to assist in alleviating strain caused by accommodative infacility by reducing the demand on the eye's focusing mechanism. | Diagnostic test | Interventional group I |
| Vision Therapy Using HART ChartIntervention Details: Participants in this group underwent vision therapy sessions utilizing the HART chart, aimed at enhancing their accommodative flexibility through repetitive focusing exercises. | Combination product | Interventional group II |
Primary outcome
Monocular and Binocular Accommodative Facility (MAF/BAF)
Time frame: 12 Months
Improvement in accommodative facility measured using Monocular and Binocular Accommodative Facility (MAF/BAF) tests with ±2.00 D flipper lenses. Measurement is recorded in cycles per minute (cpm).
subjective measures of visual comfort
Time frame: 12 Months
Reduction in symptoms of accommodative infacility assessed using a customized performa. Measurement is based on a symptom severity score recorded pre- and post-intervention.
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 27 Dec 2024.
- Individual participant dataSharing planned: No
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Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency
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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 Plus Lens Addition (+0.75 D) and Vision Therapy Using HART Chart in people with Accommodative 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 5 inclusion and 5 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 27 Dec 2024. 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?
Monocular and Binocular Accommodative Facility (MAF/BAF) (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 27 Dec 2024.