MyopiaNCT06753032
Impact of Positive & Negative Lens-Induced Defocus on Contrast-Sensitivity in Myopic & Non-Myopic Adults
A study testing Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Myopic Participants, Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Myopic Participants and Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Non-Myopic Participants in people with Myopia, run by Superior University at 1 site in Pakistan.
Trial summary
examines the influence of lens-induced defocus on contrast sensitivity-a crucial aspect of visual performance.Each participant experiences both positive and negative defocus through different lenses, with measurements taken for contrast sensitivity using the Pelli-Robson chart. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Myopic Participants, Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Myopic Participants and Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Non-Myopic Participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2024to 1 Mar 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 to 50 years.
- Participants with a confirmed diagnosis of myopia or non-myopia.
- Best corrected visual acuity of 20/30 or better.
- No history of ocular surgery or significant ocular disease.
- Informed consent was obtained.
Who cannot join
- Individuals with a history of systemic diseases affecting vision (e.g., diabetes, hypertension).
- Presence of binocular vision anomalies or strabismus.
- Pregnant or nursing women.
- Any current use of medications affecting visual function (e.g., medications causing visual side effects).
Trial locations and contacts
1 site in 1 country.
About this study
examines the influence of lens-induced defocus on contrast sensitivity-a crucial aspect of visual performance.Each participant experiences both positive and negative defocus through different lenses, with measurements taken for contrast sensitivity using the Pelli-Robson chart. Outcomes are evaluated at baseline, 2 weeks, and 4 weeks to understand the effect of defocus over time.
Read the detailed description
Additional data on symptoms like visual fatigue and computer vision syndrome are gathered using the Visual Fatigue Questionnaire (VFQ) and the Computer Vision Syndrome Questionnaire (CVS-Q), respectively. This study's findings could be instrumental in refining optical treatments, offering insights into how defocus impacts visual function across refractive conditions. Results may ultimately benefit optometric practices by guiding lens prescriptions for improved contrast sensitivity and quality of life for myopic and non-myopic individuals alike.
- Conditions
- Myopia
- Being tested
- Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Myopic Participants, Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Myopic Participants, Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Non-Myopic Participants, Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Non-Myopic Participants
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Myopic ParticipantsDiagnostic test
Intervention Description: This group will be exposed to positive defocus induced by +2.00 D spectacle lenses. The lenses are designed to create optical blur to evaluate the effects on contrast sensitivity and visual fatigue. Measurements will be conducted at baseline, 2 weeks, and 4 weeks after exposure to assess changes in visual function."
Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Myopic ParticipantsDiagnostic test
Intervention Description: This group will be exposed to negative defocus induced by -2.00 D spectacle lenses. The induced defocus will allow for the evaluation of its impact on contrast sensitivity and visual fatigue. Assessments will be carried out at baseline, 2 weeks, and 4 weeks."
Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Non-Myopic ParticipantsCombination product
ntervention Description: This group will undergo positive defocus using +2.00 D spectacle lenses. The intervention aims to examine the effect of induced defocus on contrast sensitivity and visual fatigue in non-myopic participants. Data will be collected at baseline, 2 weeks, and 4 weeks."
Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Non-Myopic ParticipantsCombination product
Intervention Description: This group will experience negative defocus induced by -2.00 D spectacle lenses. The purpose is to evaluate how negative lens-induced defocus affects contrast sensitivity and visual fatigue in non-myopic participants. Measurements will be taken at baseline, 2 weeks, and 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | Not described Receives: Diagnostic Test: Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Myopic Participants |
| Interventional group II | Experimental | Not described Receives: Diagnostic Test: Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Myopic Participants |
| Interventional group III | Active comparator | Not described Receives: Combination Product: Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Non-Myopic Participants |
| Interventional group IV | Active comparator | Not described Receives: Combination Product: Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Non-Myopic Participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast Sensitivity
Measured with the Pelli-Robson Contrast Sensitivity Chart, capturing changes in participants' ability to detect low-contrast visual stimuli under defocus conditions.
Measured: 12 Months
Visual Fatigue
Evaluated with the Visual Fatigue Questionnaire (VFQ) and Computer Vision Syndrome assessing symptoms like eye strain, discomfort, and fatigue following lens-induced defocus.
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 posted31 Dec 2024
- Study start28 Feb 2024
- Primary completion31 Jul 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT06753032
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/750
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 31 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Positive & Negative Lens-Induced Defocus on Contrast-Sensitivity in Myopic & Non-Myopic Adults
- ClinicalTrials.gov ID
- NCT06753032
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/750
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 31 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.
examines the influence of lens-induced defocus on contrast sensitivity-a crucial aspect of visual performance.Each participant experiences both positive and negative defocus through different lenses, with measurements taken for contrast sensitivity using the Pelli-Robson chart. Outcomes are evaluated at baseline, 2 weeks, and 4 weeks to understand the effect of defocus over time.
Detailed description
Additional data on symptoms like visual fatigue and computer vision syndrome are gathered using the Visual Fatigue Questionnaire (VFQ) and the Computer Vision Syndrome Questionnaire (CVS-Q), respectively. This study's findings could be instrumental in refining optical treatments, offering insights into how defocus impacts visual function across refractive conditions. Results may ultimately benefit optometric practices by guiding lens prescriptions for improved contrast sensitivity and quality of life for myopic and non-myopic individuals alike.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Diagnostic Test: Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Myopic Participants |
| Interventional group II | Experimental | Diagnostic Test: Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Myopic Participants |
| Interventional group III | Active comparator | Combination Product: Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Non-Myopic Participants |
| Interventional group IV | Active comparator | Combination Product: Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Non-Myopic Participants |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 50 years.
- Participants with a confirmed diagnosis of myopia or non-myopia.
- Best corrected visual acuity of 20/30 or better.
- No history of ocular surgery or significant ocular disease.
- Informed consent was obtained.
Key exclusion criteria (4 listed)
- Individuals with a history of systemic diseases affecting vision (e.g., diabetes, hypertension).
- Presence of binocular vision anomalies or strabismus.
- Pregnant or nursing women.
- Any current use of medications affecting visual function (e.g., medications causing visual side effects).
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 |
|---|---|---|
| Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Myopic ParticipantsIntervention Description: This group will be exposed to positive defocus induced by +2.00 D spectacle lenses. The lenses are designed to create optical blur to evaluate the effects on contrast sensitivity and visual fatigue. Measurements will be conducted at baseline, 2 weeks, and 4 weeks after exposure to assess changes in visual function." | Diagnostic test | interventional group |
| Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Myopic ParticipantsIntervention Description: This group will be exposed to negative defocus induced by -2.00 D spectacle lenses. The induced defocus will allow for the evaluation of its impact on contrast sensitivity and visual fatigue. Assessments will be carried out at baseline, 2 weeks, and 4 weeks." | Diagnostic test | Interventional group II |
| Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Non-Myopic Participantsntervention Description: This group will undergo positive defocus using +2.00 D spectacle lenses. The intervention aims to examine the effect of induced defocus on contrast sensitivity and visual fatigue in non-myopic participants. Data will be collected at baseline, 2 weeks, and 4 weeks." | Combination product | Interventional group III |
| Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Non-Myopic ParticipantsIntervention Description: This group will experience negative defocus induced by -2.00 D spectacle lenses. The purpose is to evaluate how negative lens-induced defocus affects contrast sensitivity and visual fatigue in non-myopic participants. Measurements will be taken at baseline, 2 weeks, and 4 weeks. | Combination product | Interventional group IV |
Primary outcome
Contrast Sensitivity
Time frame: 12 Months
Measured with the Pelli-Robson Contrast Sensitivity Chart, capturing changes in participants' ability to detect low-contrast visual stimuli under defocus conditions.
Visual Fatigue
Time frame: 12 months
Evaluated with the Visual Fatigue Questionnaire (VFQ) and Computer Vision Syndrome assessing symptoms like eye strain, discomfort, and fatigue following lens-induced defocus.
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 31 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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 Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Myopic Participants, Negative Lens-Induced Defocus Using Spectacle Lenses (-2.00 D) for Myopic Participants and Positive Lens-Induced Defocus Using Spectacle Lenses (+2.00 D) for Non-Myopic Participants in people with Myopia, 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 4 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 31 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?
Contrast Sensitivity (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 31 Dec 2024.