MyopiaNCT02279446
Development of a Validated Chart for Intermediate Vision Assessment
An observational study of Myopia and Hyperopia, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Hyperopia, Presbyopia
- What is being tested?
- Intermediate Visual acuity (IVA) assessment
- How many people
- 400 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2014to Apr 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Random
Who may be able to join
- native Greek participants or foreigners with perfect knowledge (verbal and written) of Greek language
Who cannot join
- glaucoma or suspicion for glaucoma,
- corneal disease or suspicion for corneal disease
- fundus disease or suspicion for fundus disease
- pregnancy or nursing,
- underlying autoimmune disease
- mental or neurologic disease
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Eye Institute Of thrace
Alexandroupoli, Evros, 68100
About this study
Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity.
Read the detailed description
Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity (IVA). It is known that no validated method for the evaluation of IVA exists.
Primary objective of the study is to validate a specific computer-based chart (optotype) that will enable: a) comparative studies among different groups of presbyopic patients with refractive errors (ie. myopia, hyperopia, and/or astigmatism), and, b) assessment of the efficacy of surgical refractive procedures (ie. LASIK) on presbyopic patients.
Intermediate Visual acuity chart is similar to the prevalent Jaeger chart. It consists of short blocks of text in various type sizes.The computer screen is set at a specific reading distance (1 meter) and the patient is asked to read the passage with the smallest type he/she can see. According to the smallest text he/she can read, IVA is classified from IVA1 (which is considered the equivalent of 20/20 distance visual acuity) to IVA5
Validation of the computer-based IVA chart will be done by correlating the results of the IVA chart to the corresponding ones from the validated 20/20 distant and Jaeger near visual acuity charts, in a random sample of study participants with different refractive errors and different near and distant visual acuities.
- Conditions
- Myopia, Hyperopia, Presbyopia, Astigmatism
- Being tested
- Intermediate Visual acuity (IVA) assessment
- Medical subject headings
- Myopia, Hyperopia, Presbyopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermediate Visual acuity (IVA) assessmentOther
Intermediate visual acuity (IVA) will be assessed with the Intermediate Visual acuity chart which is similar to the prevalent Jaeger chart. It consists of short blocks of text in various type sizes.The computer screen is set at a specific reading distance (1 meter) and the patient is asked to read the passage with the smallest type he/she can see. According to the smallest text he/she can read, IVA is classified from IVA1 (which is considered the equivalent of 20/20 distance visual acuity) to IVA5
| Study group | Role | What they receive |
|---|---|---|
| 20/20ND group | This group will have 20/20 visual acuity both in distant and near. Receives: Other: Intermediate Visual acuity (IVA) assessment | |
| 20/20D group | This group will have 20/20 distant visual acuity and variable near visual acuity. Receives: Other: Intermediate Visual acuity (IVA) assessment | |
| 20/20N group | This group will have 20/20 near visual acuity and variable distant visual acuity. Receives: Other: Intermediate Visual acuity (IVA) assessment | |
| s20/20ND group | This group will have variable near and distant visual acuity (both less than 20/20) Receives: Other: Intermediate Visual acuity (IVA) assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intermediate Visual Acuity (IVA)
Number of participants that their intermediate visual acuity measured with the "intermediate visual acuity chart" will be statistically correlated with distant visual acuity (measured by 20/20 chart) and near visual acuity (measured by Jaeger chart)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2014
- Study completionApr 2015 (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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD, PhD, Study director, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279446
- Sponsor's protocol ID
- 263/13-10-2014
- Status last verified
- Oct 2014
- First submitted
- 13 Oct 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Validated Chart for Intermediate Vision Assessment
- ClinicalTrials.gov ID
- NCT02279446
- Acronym / sponsor ID
- 263/13-10-2014
- Conditions
- Myopia, Hyperopia, Presbyopia, Astigmatism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Apr 2015 (estimated)
- First posted
- 31 Oct 2014 (estimated)
- 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.
Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity.
Detailed description
Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity (IVA). It is known that no validated method for the evaluation of IVA exists.
Primary objective of the study is to validate a specific computer-based chart (optotype) that will enable: a) comparative studies among different groups of presbyopic patients with refractive errors (ie. myopia, hyperopia, and/or astigmatism), and, b) assessment of the efficacy of surgical refractive procedures (ie. LASIK) on presbyopic patients.
Intermediate Visual acuity chart is similar to the prevalent Jaeger chart. It consists of short blocks of text in various type sizes.The computer screen is set at a specific reading distance (1 meter) and the patient is asked to read the passage with the smallest type he/she can see. According to the smallest text he/she can read, IVA is classified from IVA1 (which is considered the equivalent of 20/20 distance visual acuity) to IVA5
Validation of the computer-based IVA chart will be done by correlating the results of the IVA chart to the corresponding ones from the validated 20/20 distant and Jaeger near visual acuity charts, in a random sample of study participants with different refractive errors and different near and distant visual acuities.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20/20ND group | – | Other: Intermediate Visual acuity (IVA) assessmentThis group will have 20/20 visual acuity both in distant and near. |
| 20/20D group | – | Other: Intermediate Visual acuity (IVA) assessmentThis group will have 20/20 distant visual acuity and variable near visual acuity. |
| 20/20N group | – | Other: Intermediate Visual acuity (IVA) assessmentThis group will have 20/20 near visual acuity and variable distant visual acuity. |
| s20/20ND group | – | Other: Intermediate Visual acuity (IVA) assessmentThis group will have variable near and distant visual acuity (both less than 20/20) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Random
Key inclusion criteria (1 listed)
- native Greek participants or foreigners with perfect knowledge (verbal and written) of Greek language
Key exclusion criteria (6 listed)
- glaucoma or suspicion for glaucoma,
- corneal disease or suspicion for corneal disease
- fundus disease or suspicion for fundus disease
- pregnancy or nursing,
- underlying autoimmune disease
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 |
|---|---|---|
| Intermediate Visual acuity (IVA) assessmentIntermediate visual acuity (IVA) will be assessed with the Intermediate Visual acuity chart which is similar to the prevalent Jaeger chart. It consists of short blocks of text in various type sizes.The computer screen is set at a specific reading distance (1 meter) and the patient is asked to read the passage with the smallest type he/she can see. According to the smallest text he/she can read, IVA is classified from IVA1 (which is considered the equivalent of 20/20 distance visual acuity) to IVA5 | Other | 20/20D group, 20/20N group, 20/20ND group, s20/20ND group |
Primary outcome
Intermediate Visual Acuity (IVA)
Time frame: 6 months
Number of participants that their intermediate visual acuity measured with the "intermediate visual acuity chart" will be statistically correlated with distant visual acuity (measured by 20/20 chart) and near visual acuity (measured by Jaeger chart)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
Related trials for Myopia
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
Recruiting
Wavelength Intervention for Nearsighted Kids
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.
Georgios Labiris, MD, PhD study director
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Hyperopia, run by Democritus University of Thrace at 1 site in Greece.
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 1 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 31 Oct 2014. 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 Greece. 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?
Contact Georgios Labiris, MD, PhD (00302551039891, labiris@usa.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intermediate Visual Acuity (IVA) (time frame: 6 months). 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 Oct 2014.