- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06484257
Comparison Between Myopia Versus Hypermetropia With Progressive Addition Lenses in Computer Users
June 26, 2024 updated by: Muhammad Naveed Babur, Superior University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- The Keratoconus center, Eye 2 Eye Optometrists, 13 D valencia housing society
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Myopia
|
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.
|
|
Other: Hypermetropia
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 Months
|
|
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.
|
12 months
|
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
June 1, 2024
Study Completion (Estimated)
October 30, 2024
Study Registration Dates
First Submitted
June 26, 2024
First Submitted That Met QC Criteria
June 26, 2024
First Posted (Actual)
July 3, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
June 26, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall22/732
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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