PresbyopiaNCT05005624
Validation of an Activities-of-daily-living Framework at Different Light Conditions
An observational study of Presbyopia and Near Vision, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Primary objective of this study is the construction and validation of an experimental environment for the simulation of a variety of near- and intermediate-vision activities of daily living (ADLs) in different combinations of light temperature and light intensity. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Near Vision, Reading
- What is being tested?
- ADL performance
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2020to 30 Jun 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normophakic participants with a clear natural lens
Who may be able to join
- normophakic participants with a clear natural lens
- age between 40 to 75 years old
- UNVA: logMAR 0.1, 0.4, or 0.7
Who cannot join
- astigmatism >1.00 diopters
- glaucoma
- intraocular pressure lowering medications
- former incisional eye surgery
- corneal or fundus disease
- diabetes mellitus
- autoimmune diseases
- neurological, psychiatric or mental diseases
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Ophthalmology, University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
About this study
Official title: Validation of an Activities-of-daily-living Framework at Different Combinations of Light Temperature and Light Intensity
Primary objective of this study is the construction and validation of an experimental environment for the simulation of a variety of near- and intermediate-vision activities of daily living (ADLs) in different combinations of light temperature and light intensity.
Read the detailed description
Among the objectives of the study is to validate a framework of ADLs that require near and intermediate vision and better reflect visual capacity, in a special experimental environment of 9 different combinations of light temperature and light intensity.
The final list consists of the following ten basic ADL tasks:
- Phone Book Search (PBS), 2. Supermarket receipt (SupRe), 3. Book reading (BR), 4. Cellular message (CM), 5. Cellular entry search (CES), 6. Reading computer screen (RCS), 7. Drops bottle reading (DR), 8. Subtitles reading (SubRe), 9. Open door test (ODT), and, 10. Screwdriver test (ST).
The 9 light combinations are the following:
3000 K - 25 fc, 3000 K - 50 fc, 3000 K - 75 fc 4000 K - 25 fc, 4000 K - 50 fc, 4000 K - 75 fc 6000 K - 25 fc, 6000 K - 50 fc, 6000 K - 75 fc
- Conditions
- Presbyopia, Near Vision, Reading, Daily Activities
- Being tested
- ADL performance
- Keywords
- activities of daily living, presbyopia, light temperature, light intensity
- Medical subject headings
- Presbyopia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADL performanceOther
All validation groups address the following ten ADL tasks in 9 different combinations of light temperature (in Kelvins - K) and light intensity (in foot candles - fc) in order possible differences to be revealed among the validation groups and light combinations:
- Phone Book Search (PBS), 2. Supermarket receipt (SupRe), 3. Book reading (BR), 4. Cellular message (CM), 5. Cellular entry search (CES), 6. Reading computer screen (RCS), 7. Drops bottle reading (DR), 8. Subtitles reading (SubRe), 9. Open door test (ODT), and, 10. Screwdriver test (ST).
The 9 light combinations are the following:
3000 K - 25 fc, 3000 K - 50 fc, 3000 K - 75 fc 4000 K - 25 fc, 4000 K - 50 fc, 4000 K - 75 fc 6000 K - 25 fc, 6000 K - 50 fc, 6000 K - 75 fc
| Study group | Role | What they receive |
|---|---|---|
| Validation group 1 (VG-1) | 20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.1 logMAR (Snellen 20/25) Receives: Other: ADL performance | |
| Validation group 2 (VG-2) | 20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.4 logMAR (Snellen 20/50) Receives: Other: ADL performance | |
| Validation group 3 (VG-3) | 20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.7 logMAR (Snellen 20/100) Receives: Other: ADL performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phone Book Search (PBS) score
Patient is required to find and read a specific entry in a regular phonebook catalog in the nine different combinations of light temperature and light intensity. A different entry is asked to be found in each combination.
[scale's best value: 100, scale's worst value: 0]
Measured: through study completion, an average of 6 months
Supermarket Receipt (SupRe) score
Patient is required to find and read three products from a typical supermarket receipt in the nine different combinations of light temperature and light intensity. Different products are asked to be found in each combination.
[scale's best value: 100, scale's worst value: 0]
Measured: through study completion, an average of 6 months
Book Reading (BR) score
Patient is required to read an excerpt of a predetermined length in a novel in the nine different combinations of light temperature and light intensity. A different excerpt of the same length is asked to be read in each combination.
[scale's best value: 100, scale's worst value: 0]
Measured: through study completion, an average of 6 months
Cellular message (CM) score
Patient is required to read a Short Message Service (SMS) on a cellular phone in the nine different combinations of light temperature and light intensity. A different SMS is asked to be read in each combination.
[scale's best value: 100, scale's worst value: 0]
Measured: through study completion, an average of 6 months
Cellular Entry Search (CES) score
Patient is required to find and read one specific entry on a cellular phone in the nine different combinations of light temperature and light intensity. Different entries are asked to be found in each combination.
[scale's best value: 100, scale's worst value: 0]
Measured: through study completion, an average of 6 months
Reading Computer Screen (RCS) score
Patient is required to correctly read text of a predetermined length from a computer screen in the nine different combinations of light temperature and light intensity. Different texts of the same length are asked to be read in each combination.
[scale's best value: 100, scale's worst value: 0]
Measured: through study completion, an average of 6 months
Drops bottle Reading (DR) score
Patient is required to correctly read the expiration date printed on three typical eye dropper bottles in the nine different combinations of light temperature and light intensity. Different eye dropper bottles are given to be read in each combination.
[scale's best value: 100, scale's worst value: 0]
Measured: through study completion, an average of 6 months
Subtitles Reading (SubRe) score
Patient is required to correctly read movie subtitles from a one-minute movie excerpt on a computer screen in the nine different combinations of light temperature and light intensity. Different movie excerpts are shown in each combination.
[scale's best value: 100, scale's worst value: 0]
Measured: through study completion, an average of 6 months
Open Door Test (ODT) score
Patient is required to find a specific key from a keychain that holds 10 keys and put it in the corresponding door keyhole in the nine different combinations of light temperature and light intensity. Different keychains are given in each combination.
[scale's best value: 100, scale's worst value: 0]
Measured: through study completion, an average of 6 months
Screwdriver Test (ST) score
Patient is required to select one among three screwdrivers and insert it in the appropriate screw among a variety of screw types in the nine different combinations of light temperature and light intensity. Different screwdrivers are given to be selected in each combination.
[scale's best value: 100, scale's worst value: 0]
Measured: through study completion, an average of 6 months
Secondary outcomes (4)
Uncorrected Distance Visual Acuity (UDVA)
Monocular and binocular UDVA of all groups is estimated using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance
Measured: through study completion, an average of 6 months
Uncorrected Intermediate Visual Acuity (UIVA)
Monocular and binocular UIVA of all groups is estimated using web-based Democritus Digital Acuity Reading Test (wDDART)
Measured: through study completion, an average of 6 months
Uncorrected Near Visual Acuity (UNVA)
Monocular and binocular UNVA of all groups is estimated using web-based Democritus Digital Acuity Reading Test (wDDART)
Measured: through study completion, an average of 6 months
25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) score
Vision-specific quality of life of all participants is evaluated with the Greek version of NEI VFQ-25, which is handed to the patients prior to their ADL assessment.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Jul 2020
- Primary completion23 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (actual)
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
- NCT05005624
- Sponsor's protocol ID
- DUTH/EHDE9/29-5-2020
- Status last verified
- Apr 2022
- First submitted
- 10 Aug 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Activities-of-daily-living Framework at Different Combinations of Light Temperature and Light Intensity
- ClinicalTrials.gov ID
- NCT05005624
- Acronym / sponsor ID
- DUTH/EHDE9/29-5-2020
- Conditions
- Presbyopia, Near Vision, Reading, Daily Activities
- Keywords
- activities of daily living, presbyopia, light temperature, light intensity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 13 Aug 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.
Primary objective of this study is the construction and validation of an experimental environment for the simulation of a variety of near- and intermediate-vision activities of daily living (ADLs) in different combinations of light temperature and light intensity.
Detailed description
Among the objectives of the study is to validate a framework of ADLs that require near and intermediate vision and better reflect visual capacity, in a special experimental environment of 9 different combinations of light temperature and light intensity.
The final list consists of the following ten basic ADL tasks:
- Phone Book Search (PBS), 2. Supermarket receipt (SupRe), 3. Book reading (BR), 4. Cellular message (CM), 5. Cellular entry search (CES), 6. Reading computer screen (RCS), 7. Drops bottle reading (DR), 8. Subtitles reading (SubRe), 9. Open door test (ODT), and, 10. Screwdriver test (ST).
The 9 light combinations are the following:
3000 K - 25 fc, 3000 K - 50 fc, 3000 K - 75 fc 4000 K - 25 fc, 4000 K - 50 fc, 4000 K - 75 fc 6000 K - 25 fc, 6000 K - 50 fc, 6000 K - 75 fc
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Validation group 1 (VG-1) | – | Other: ADL performance20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.1 logMAR (Snellen 20/25) |
| Validation group 2 (VG-2) | – | Other: ADL performance20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.4 logMAR (Snellen 20/50) |
| Validation group 3 (VG-3) | – | Other: ADL performance20 participants with binocular Uncorrected Near Visual Acuity (UNVA) 0.7 logMAR (Snellen 20/100) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normophakic participants with a clear natural lens
Key inclusion criteria (3 listed)
- normophakic participants with a clear natural lens
- age between 40 to 75 years old
- UNVA: logMAR 0.1, 0.4, or 0.7
Key exclusion criteria (8 listed)
- astigmatism >1.00 diopters
- glaucoma
- intraocular pressure lowering medications
- former incisional eye surgery
- corneal or fundus 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 |
|---|---|---|
| ADL performanceAll validation groups address the following ten ADL tasks in 9 different combinations of light temperature (in Kelvins - K) and light intensity (in foot candles - fc) in order possible differences to be revealed among the validation groups and light combinations: 1. Phone Book Search (PBS), 2. Supermarket receipt (SupRe), 3. Book reading (BR), 4. Cellular message (CM), 5. Cellular entry search (CES), 6. Reading computer screen (RCS), 7. Drops bottle reading (DR), 8. Subtitles reading (SubRe), 9. Open door test (ODT), and, 10. Screwdriver test (ST). The 9 light combinations are the following: 3000 K - 25 fc, 3000 K - 50 fc, 3000 K - 75 fc 4000 K - 25 fc, 4000 K - 50 fc, 4000 K - 75 fc 6000 K - 25 fc, 6000 K - 50 fc, 6000 K - 75 fc | Other | Validation group 1 (VG-1), Validation group 2 (VG-2), Validation group 3 (VG-3) |
Primary outcome
Phone Book Search (PBS) score
Time frame: through study completion, an average of 6 months
Patient is required to find and read a specific entry in a regular phonebook catalog in the nine different combinations of light temperature and light intensity. A different entry is asked to be found in each combination. [scale's best value: 100, scale's worst value: 0]
Supermarket Receipt (SupRe) score
Time frame: through study completion, an average of 6 months
Patient is required to find and read three products from a typical supermarket receipt in the nine different combinations of light temperature and light intensity. Different products are asked to be found in each combination. [scale's best value: 100, scale's worst value: 0]
Book Reading (BR) score
Time frame: through study completion, an average of 6 months
Patient is required to read an excerpt of a predetermined length in a novel in the nine different combinations of light temperature and light intensity. A different excerpt of the same length is asked to be read in each combination. [scale's best value: 100, scale's worst value: 0]
Cellular message (CM) score
Time frame: through study completion, an average of 6 months
Patient is required to read a Short Message Service (SMS) on a cellular phone in the nine different combinations of light temperature and light intensity. A different SMS is asked to be read in each combination. [scale's best value: 100, scale's worst value: 0]
Cellular Entry Search (CES) score
Time frame: through study completion, an average of 6 months
Patient is required to find and read one specific entry on a cellular phone in the nine different combinations of light temperature and light intensity. Different entries are asked to be found in each combination. [scale's best value: 100, scale's worst value: 0]
Reading Computer Screen (RCS) score
Time frame: through study completion, an average of 6 months
Patient is required to correctly read text of a predetermined length from a computer screen in the nine different combinations of light temperature and light intensity. Different texts of the same length are asked to be read in each combination. [scale's best value: 100, scale's worst value: 0]
Drops bottle Reading (DR) score
Time frame: through study completion, an average of 6 months
Patient is required to correctly read the expiration date printed on three typical eye dropper bottles in the nine different combinations of light temperature and light intensity. Different eye dropper bottles are given to be read in each combination. [scale's best value: 100, scale's worst value: 0]
Subtitles Reading (SubRe) score
Time frame: through study completion, an average of 6 months
Patient is required to correctly read movie subtitles from a one-minute movie excerpt on a computer screen in the nine different combinations of light temperature and light intensity. Different movie excerpts are shown in each combination. [scale's best value: 100, scale's worst value: 0]
Open Door Test (ODT) score
Time frame: through study completion, an average of 6 months
Patient is required to find a specific key from a keychain that holds 10 keys and put it in the corresponding door keyhole in the nine different combinations of light temperature and light intensity. Different keychains are given in each combination. [scale's best value: 100, scale's worst value: 0]
Screwdriver Test (ST) score
Time frame: through study completion, an average of 6 months
Patient is required to select one among three screwdrivers and insert it in the appropriate screw among a variety of screw types in the nine different combinations of light temperature and light intensity. Different screwdrivers are given to be selected in each combination. [scale's best value: 100, scale's worst value: 0]
4 secondary outcomes
Uncorrected Distance Visual Acuity (UDVA)
Time frame: through study completion, an average of 6 months
Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: through study completion, an average of 6 months
Uncorrected Near Visual Acuity (UNVA)
Time frame: through study completion, an average of 6 months
25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) score
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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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 3 inclusion and 8 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: finished, as of the sponsor's last update on 4 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phone Book Search (PBS) score (time frame: through study completion, an average of 6 months). The study lists 10 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 4 May 2022.