PresbyopiaNCT04739085
Level of Agreement Between Clinical Defocus Curves and the Web-based Democritus Digital Acuity Reading Test wDDART
An observational study of Presbyopia and Near Vision, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
The primary objective of this study is to compare the level of agreement between clinical defocus curves and the web Democritus Digital Acuity Reading Test (wDDART), which is a web-based digital near and intermediate vision reading test. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Presbyopia, Near Vision
- What is being tested?
- Defocus curves - Monocular distance visual acuity with trial lenses added to the best correction for distance and wDDART - Monocular near visual acuity using the best correction for distance
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 20 Nov 2020to 20 May 2021
- How long will I take part?
- 15 Days
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with previous cataract lens extraction will be categorized into the following groups: 1. Monofocal group 2. Monovision group (monofocal IOLs bilaterally) 3. Hybrid monovision group (monofocal IOL in the dominant eye and multifocal IOL in the recessive eye) 4. Bilateral multifocal group (the same multifocal IOLs bilaterally) 5. Premium monovision group [bifocal hybrid IOL (Restor +2.50 diopters, Alcon) in the dominant eye and trifocal diffractive IOL (Panoptix, Alcon) in the recessive eye]
Who may be able to join
- Previous cataract lens extraction, age> 40 years, monocular best corrected distance visual acuity > 7/10
Who cannot join
- Glaucoma, corneal diseases, macular diseases, postoperative opacification of the posterior capsule, former mental diseases
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
Georgios Labiris, MD, PhD, 00302551030405, labiris@usa.net
Eleftheria Chalkia, 00302551030405, echalkia@med.duth.gr
About this study
Official title: Level of Agreement Between Clinical Defocus Curves and the Near and Intermediate Vision Web-based Democritus Digital Acuity Reading Test wDDART: a Comparative Study
The primary objective of this study is to compare the level of agreement between clinical defocus curves and the web Democritus Digital Acuity Reading Test (wDDART), which is a web-based digital near and intermediate vision reading test.
Read the detailed description
The 'defocus curve' assessment technique aims to simulate different distances from near to far over which the patient's visual acuity (VA) is evaluated. Defocus curves are created by first measuring best-corrected distance and near VA of the examinee. Then, a series of positive- and negative-powered trial lenses are added to the best-corrected distance visual acuity (BCDVA) of the patient's eye. Viewing through the addition of a minus lens creates divergent light rays with the same refractive effect as bringing the eye chart closer to the viewer. For instance, a -2.50 D lens represents the distance of 40 cm.
The "defocus curve" assessment technique is a method used widely for the assessment of the functional vision range following multifocal intraocular lens (IOL) implantation. Since this method is a simulation of the near vision, it would be ideal if near vision could be evaluated objectively with a near vision chart. However, the conventional printed near vision charts are not available for a variety of reading distances. In addition, the measurement of near VA at different distances with a printed reading chart intended for one predefined distance (e.g. printed chart for 40 cm) and the transformation of the reading score at 40 cm to an equivalent score for the examined distances is impractical in clinical setting.
For this reason, a digital reading test that allows the text calibration for all reading distances could be a practical method for the rapid and ease evaluation of the near VA, especially in patients implanted with multifocal IOLs. The web-based digital near and intermediate vision reading test wDDART offers the ability to estimate VA at different distances with automated measurement of the patient-screen distance.
Therefore, the present study aims to investigate the level of agreement between clinical defocus curves and the web-based digital near and intermediate vision reading test wDDART.
- Conditions
- Presbyopia, Near Vision
- Being tested
- Defocus curves - Monocular distance visual acuity with trial lenses added to the best correction for distance, wDDART - Monocular near visual acuity using the best correction for distance
- Keywords
- defocus curves, multifocal IOL implantation, wDDART
- Medical subject headings
- Presbyopia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defocus curves - Monocular distance visual acuity with trial lenses added to the best correction for distanceDiagnostic test
The monocular distance visual acuity of each participant' eye is evaluated using trial lenses of -3.00 sph, -2.50 sph, -1.75 sph, and -1.25 sph (added to the best correction for distance), which correspond to distances 30 cm, 40 cm, 60 cm and 80 cm, respectively.
wDDART - Monocular near visual acuity using the best correction for distanceDiagnostic test
The same participants undergo visual acuity test via the web-based digital near vision reading test wDDART at 30 cm, 40 cm, 60 cm and 80 cm, having their best correction for distance.
| Study group | Role | What they receive |
|---|---|---|
| Defocus curve group | The monocular distance visual acuity of each participant' eye is evaluated using trial lenses of -3.00 sph, -2.50 sph, -1.75 sph, and -1.25 sph (added to the best correction for distance), which correspond to the distances of 30 cm, 40 cm, 60 cm, and 80 cm, respectively. Receives: Diagnostic Test: Defocus curves - Monocular distance visual acuity with trial lenses added to the best correction for distance | |
| wDDART group | The same participants undergo visual acuity test via the web-based digital near vision reading test wDDART at 30 cm, 40 cm, 60 cm and 80 cm, having their best correction for distance. Receives: Diagnostic Test: wDDART - Monocular near visual acuity using the best correction for distance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance-corrected near visual acuity (DCNVA) at 30 cm via defocus curves
The monocular distance visual acuity of each participant's eye is evaluated using a trial lens of -3.00 sph (added to the best correction for distance), which corresponds to the distance of 30 cm
Measured: through study completion, 6 months
Distance-corrected near visual acuity (DCNVA) at 40 cm via defocus curves
The monocular distance visual acuity of each participant's eye is evaluated using a trial lens of -2.50 sph (added to the best correction for distance), which corresponds to the distance of 40 cm
Measured: through study completion, 6 months
Distance-corrected intermediate visual acuity (DCIVA) at 60 cm via defocus curves
The monocular distance visual acuity of each participant's eye is evaluated using a trial lens of -1.75 sph (added to the best correction for distance), which corresponds to the distance of 60 cm
Measured: through study completion, 6 months
Distance-corrected intermediate visual acuity (DCIVA) at 80 cm via defocus curves
The monocular distance visual acuity of each participant's eye is evaluated using a trial lens of -1.25 sph (added to the best correction for distance), which corresponds to the distance of 80 cm
Measured: through study completion, 6 months
Distance-corrected near visual acuity (DCNVA) at 30 cm via wDDART
The monocular near (30 cm) visual acuity of each participant's eye is evaluated using the best correction for distance
Measured: through study completion, 6 months
Distance-corrected near visual acuity (DCNVA) at 40 cm via wDDART
The monocular near (40 cm) visual acuity of each participant's eye is evaluated using the best correction for distance
Measured: through study completion, 6 months
Distance-corrected intermediate visual acuity (DCIVA) at 60 cm via wDDART
The monocular intermediate (60 cm) visual acuity of each participant's eye is evaluated using the best correction for distance
Measured: through study completion, 6 months
Distance-corrected intermediate visual acuity (DCIVA) at 80 cm via wDDART
The monocular intermediate (80 cm) visual acuity of each participant's eye is evaluated using the best correction for distance
Measured: through study completion, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start20 Nov 2020
- Primary completion20 Mar 2021 (estimated)
- Study completion20 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 15 Days
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 chair, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739085
- Sponsor's protocol ID
- ES1/Th4/21-1-2021
- Status last verified
- Jan 2021
- First submitted
- 31 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Labiris G, Panagiotopoulou EK, Chatzimichael E, Tzinava M, Mataftsi A, Delibasis K. Introduction of a digital near-vision reading test for normal and low vision adults: development and validation. Eye Vis (Lond). 2020 Oct 22;7:51. doi: 10.1186/s40662-020-00216-0. eCollection 2020.
PubMed 33102611
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level of Agreement Between Clinical Defocus Curves and the Near and Intermediate Vision Web-based Democritus Digital Acuity Reading Test wDDART: a Comparative Study
- ClinicalTrials.gov ID
- NCT04739085
- Acronym / sponsor ID
- ES1/Th4/21-1-2021
- Conditions
- Presbyopia, Near Vision
- Keywords
- defocus curves, multifocal IOL implantation, wDDART
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 20 Mar 2021 (estimated)
- Study completion
- 20 May 2021 (estimated)
- First posted
- 4 Feb 2021 (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.
The primary objective of this study is to compare the level of agreement between clinical defocus curves and the web Democritus Digital Acuity Reading Test (wDDART), which is a web-based digital near and intermediate vision reading test.
Detailed description
The 'defocus curve' assessment technique aims to simulate different distances from near to far over which the patient's visual acuity (VA) is evaluated. Defocus curves are created by first measuring best-corrected distance and near VA of the examinee. Then, a series of positive- and negative-powered trial lenses are added to the best-corrected distance visual acuity (BCDVA) of the patient's eye. Viewing through the addition of a minus lens creates divergent light rays with the same refractive effect as bringing the eye chart closer to the viewer. For instance, a -2.50 D lens represents the distance of 40 cm.
The "defocus curve" assessment technique is a method used widely for the assessment of the functional vision range following multifocal intraocular lens (IOL) implantation. Since this method is a simulation of the near vision, it would be ideal if near vision could be evaluated objectively with a near vision chart. However, the conventional printed near vision charts are not available for a variety of reading distances. In addition, the measurement of near VA at different distances with a printed reading chart intended for one predefined distance (e.g. printed chart for 40 cm) and the transformation of the reading score at 40 cm to an equivalent score for the examined distances is impractical in clinical setting.
For this reason, a digital reading test that allows the text calibration for all reading distances could be a practical method for the rapid and ease evaluation of the near VA, especially in patients implanted with multifocal IOLs. The web-based digital near and intermediate vision reading test wDDART offers the ability to estimate VA at different distances with automated measurement of the patient-screen distance.
Therefore, the present study aims to investigate the level of agreement between clinical defocus curves and the web-based digital near and intermediate vision reading test wDDART.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Defocus curve group | – | Diagnostic Test: Defocus curves - Monocular distance visual acuity with trial lenses added to the best correction for distanceThe monocular distance visual acuity of each participant' eye is evaluated using trial lenses of -3.00 sph, -2.50 sph, -1.75 sph, and -1.25 sph (added to the best correction for distance), which correspond to the distances of 30 cm, 40 cm, 60 cm, and 80 cm, respectively. |
| wDDART group | – | Diagnostic Test: wDDART - Monocular near visual acuity using the best correction for distanceThe same participants undergo visual acuity test via the web-based digital near vision reading test wDDART at 30 cm, 40 cm, 60 cm and 80 cm, having their best correction for distance. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with previous cataract lens extraction will be categorized into the following groups: 1. Monofocal group 2. Monovision group (monofocal IOLs bilaterally) 3. Hybrid monovision group (monofocal IOL in the dominant eye and multifocal IOL in the recessive eye) 4. Bilateral multifocal group (the same multifocal IOLs bilaterally) 5. Premium monovision group [bifocal hybrid IOL (Restor +2.50 diopters, Alcon) in the dominant eye and trifocal diffractive IOL (Panoptix, Alcon) in the recessive eye]
Key inclusion criteria (1 listed)
- Previous cataract lens extraction, age> 40 years, monocular best corrected distance visual acuity > 7/10
Key exclusion criteria (1 listed)
- Glaucoma, corneal diseases, macular diseases, postoperative opacification of the posterior capsule, former mental diseases
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 |
|---|---|---|
| Defocus curves - Monocular distance visual acuity with trial lenses added to the best correction for distanceThe monocular distance visual acuity of each participant' eye is evaluated using trial lenses of -3.00 sph, -2.50 sph, -1.75 sph, and -1.25 sph (added to the best correction for distance), which correspond to distances 30 cm, 40 cm, 60 cm and 80 cm, respectively. | Diagnostic test | Defocus curve group |
| wDDART - Monocular near visual acuity using the best correction for distanceThe same participants undergo visual acuity test via the web-based digital near vision reading test wDDART at 30 cm, 40 cm, 60 cm and 80 cm, having their best correction for distance. | Diagnostic test | wDDART group |
Primary outcome
Distance-corrected near visual acuity (DCNVA) at 30 cm via defocus curves
Time frame: through study completion, 6 months
The monocular distance visual acuity of each participant's eye is evaluated using a trial lens of -3.00 sph (added to the best correction for distance), which corresponds to the distance of 30 cm
Distance-corrected near visual acuity (DCNVA) at 40 cm via defocus curves
Time frame: through study completion, 6 months
The monocular distance visual acuity of each participant's eye is evaluated using a trial lens of -2.50 sph (added to the best correction for distance), which corresponds to the distance of 40 cm
Distance-corrected intermediate visual acuity (DCIVA) at 60 cm via defocus curves
Time frame: through study completion, 6 months
The monocular distance visual acuity of each participant's eye is evaluated using a trial lens of -1.75 sph (added to the best correction for distance), which corresponds to the distance of 60 cm
Distance-corrected intermediate visual acuity (DCIVA) at 80 cm via defocus curves
Time frame: through study completion, 6 months
The monocular distance visual acuity of each participant's eye is evaluated using a trial lens of -1.25 sph (added to the best correction for distance), which corresponds to the distance of 80 cm
Distance-corrected near visual acuity (DCNVA) at 30 cm via wDDART
Time frame: through study completion, 6 months
The monocular near (30 cm) visual acuity of each participant's eye is evaluated using the best correction for distance
Distance-corrected near visual acuity (DCNVA) at 40 cm via wDDART
Time frame: through study completion, 6 months
The monocular near (40 cm) visual acuity of each participant's eye is evaluated using the best correction for distance
Distance-corrected intermediate visual acuity (DCIVA) at 60 cm via wDDART
Time frame: through study completion, 6 months
The monocular intermediate (60 cm) visual acuity of each participant's eye is evaluated using the best correction for distance
Distance-corrected intermediate visual acuity (DCIVA) at 80 cm via wDDART
Time frame: through study completion, 6 months
The monocular intermediate (80 cm) visual acuity of each participant's eye is evaluated using the best correction for distance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Background: PubMed 33102611Labiris G, Panagiotopoulou EK, Chatzimichael E, Tzinava M, Mataftsi A, Delibasis K. Introduction of a digital near-vision reading test for normal and low vision adults: development and validation. Eye Vis (Lond). 2020 Oct 22;7:51. doi: 10.1186/s40662-020-00216-0. eCollection 2020.
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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.
Georgios Labiris, MD, PhD study chair
Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
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 Presbyopia and Near Vision, 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 1 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 4 Feb 2021. 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 (00302551030405, labiris@usa.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance-corrected near visual acuity (DCNVA) at 30 cm via defocus curves (time frame: through study completion, 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04739085, which also lists 1 linked publication.
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 4 Feb 2021.