MyopiaNCT06484257
Comparison Between Myopia Versus Hypermetropia With Progressive Addition Lenses in Computer Users
A study testing Myopia and Hypermetropia in people with Myopia and Hypermetropia, run by Superior University at 1 site in Pakistan.
Trial summary
This study examines how myopia (nearsightedness) and hyperopia (farsightedness) affect the use of progressive addition lenses (PALs) for computer users. PALs offer a range of vision correction within one lens, ideal for presbyopia (age-related near focusing difficulty). Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Myopia, Hypermetropia
- What is being tested?
- Myopia and Hypermetropia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The age of Participant will be 40 to 55 years
- Participant diagnosed with myopia having -0.50 to -3.00DS and astigmatism up to -0.75DC
- Patient diagnosed with Hypermetropia having +050 to +3.00 DS and Astigmatism up to +0.75DC
- Presbyopia addition will range from +1.00 to +2.50 DS
- Participants who have worked more than 4 hours on the computer screen.
- Participants who will be already progressive users and first-time users.
- Patients with no Ocular disease.
Who cannot join
- Participants with Pre Presbyopia and above 55 years of age
- Participants with significant ocular disease.
- Participants with uncontrolled diabetes and hypertension
- Participants who will not be willing for PAL,s
- Participants with more than 0.75 astigmatism
- Participants with known allergies and sensitivity.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The Keratoconus center, Eye 2 Eye Optometrists, 13 D valencia housing society
Lahore, Punjab Province
About this study
This study examines how myopia (nearsightedness) and hyperopia (farsightedness) affect the use of progressive addition lenses (PALs) for computer users. PALs offer a range of vision correction within one lens, ideal for presbyopia (age-related near focusing difficulty). We'll compare visual comfort, eye strain, and user preference for PALs between myopic and hyperopic individuals while focusing on computer screens.
Read the detailed description
The research will also consider if general-purpose PALs differ from computer-specific PALs in these user groups, and how presbyopia progression might influence PAL effectiveness for each condition. This information can help eye doctors recommend the most suitable PAL design for computer users with myopia or hyperopia.
- Conditions
- Myopia, Hypermetropia
- Being tested
- Myopia, Hypermetropia
- Medical subject headings
- Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyopiaBehavioural
Participants in this arm would receive progressive addition lenses specifically designed to correct myopia. These lenses would typically have a prescription for correcting nearsightedness (myopia) in addition to any other vision corrections needed, such as astigmatism correction and presbyopia. The participants would wear these lenses while using computers according to the study protocol.
HypermetropiaOther
Participants in this arm would receive progressive addition lenses specifically designed to correct hypermetropia. These lenses would typically have a prescription for correcting farsightedness (hypermetropia) in addition to any other vision corrections needed, such as astigmatism correction and presbyopia. The participants would wear these lenses while using computers according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Myopia | Active comparator | Not described Receives: Behavioral: Myopia |
| Hypermetropia | Other | Not described Receives: Other: Hypermetropia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Assessing visual acuity at different distances, including distance vision (for activities such as viewing the computer screen) and near vision (for reading text on the screen), while wearing progressive addition lenses.
Measured: 12 Months
Subjective Visual Comfort
Using standardized questionnaires or subjective ratings from participants to assess their comfort level while using computers with progressive addition lenses.
Measured: 12 months
Visual Fatigue
Assessing the level of visual fatigue experienced by participants during or after prolonged computer use with the progressive addition lenses. This could involve subjective ratings of eye strain, tiredness, or discomfort.
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 posted3 Jul 2024
- Study start1 Nov 2023
- Primary completion1 Jun 2024
- Study completion30 Oct 2024 (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.
- 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
- 64 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
- NCT06484257
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/732
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Myopia Versus Hypermetropia With Progressive Addition Lenses in Computer Users
- ClinicalTrials.gov ID
- NCT06484257
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/732
- Conditions
- Myopia, Hypermetropia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 3 Jul 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 study examines how myopia (nearsightedness) and hyperopia (farsightedness) affect the use of progressive addition lenses (PALs) for computer users. PALs offer a range of vision correction within one lens, ideal for presbyopia (age-related near focusing difficulty). We'll compare visual comfort, eye strain, and user preference for PALs between myopic and hyperopic individuals while focusing on computer screens.
Detailed description
The research will also consider if general-purpose PALs differ from computer-specific PALs in these user groups, and how presbyopia progression might influence PAL effectiveness for each condition. This information can help eye doctors recommend the most suitable PAL design for computer users with myopia or hyperopia.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myopia | Active comparator | Behavioral: Myopia |
| Hypermetropia | Other | Other: Hypermetropia |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The age of Participant will be 40 to 55 years
- Participant diagnosed with myopia having -0.50 to -3.00DS and astigmatism up to -0.75DC
- Patient diagnosed with Hypermetropia having +050 to +3.00 DS and Astigmatism up to +0.75DC
- Presbyopia addition will range from +1.00 to +2.50 DS
- Participants who have worked more than 4 hours on the computer screen.
Key exclusion criteria (6 listed)
- Participants with Pre Presbyopia and above 55 years of age
- Participants with significant ocular disease.
- Participants with uncontrolled diabetes and hypertension
- Participants who will not be willing for PAL,s
- Participants with more than 0.75 astigmatism
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 |
|---|---|---|
| MyopiaParticipants in this arm would receive progressive addition lenses specifically designed to correct myopia. These lenses would typically have a prescription for correcting nearsightedness (myopia) in addition to any other vision corrections needed, such as astigmatism correction and presbyopia. The participants would wear these lenses while using computers according to the study protocol. | Behavioural | Myopia |
| HypermetropiaParticipants in this arm would receive progressive addition lenses specifically designed to correct hypermetropia. These lenses would typically have a prescription for correcting farsightedness (hypermetropia) in addition to any other vision corrections needed, such as astigmatism correction and presbyopia. The participants would wear these lenses while using computers according to the study protocol. | Other | Hypermetropia |
Primary outcome
Visual Acuity
Time frame: 12 Months
Assessing visual acuity at different distances, including distance vision (for activities such as viewing the computer screen) and near vision (for reading text on the screen), while wearing progressive addition lenses.
Subjective Visual Comfort
Time frame: 12 months
Using standardized questionnaires or subjective ratings from participants to assess their comfort level while using computers with progressive addition lenses.
Visual Fatigue
Time frame: 12 months
Assessing the level of visual fatigue experienced by participants during or after prolonged computer use with the progressive addition lenses. This could involve subjective ratings of eye strain, tiredness, or discomfort.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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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 Myopia and Hypermetropia in people with Myopia and Hypermetropia, 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Jul 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?
Results are not available in the source record.
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?
Visual Acuity (time frame: 12 Months). The study lists 3 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 3 Jul 2024.