PresbyopiaNCT05359380
The Impact of Light Conditions on the Efficacy of Multifocal Intraocular Lens Implantation in Activities of Daily Living
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 to identify the optimal task lighting conditions (in terms of light intensity and light temperature) for 10 activities of daily living (ADLs) that require near or intermediate vision acuity in a validated ADL simulation framework for a sample of patients who underwent presbyopic… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Presbyopia, Near Vision, Reading
- What is being tested?
- ADL performance
- How many people
- 75 participants
- Where
- 1 siteGreece
- Study dates
- 15 Sep 2021to 15 Sep 2022
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent phacoemulsification and bilateral implantation of IOLs [SG1: trifocal diffractive IOL, SG2: bifocal hybrid (diffractive - refractive) IOL, SG3: monofocal IOL]
Who may be able to join
- Age older than 18 years old
- Diagnosis of senile cataract either stage 2 or 3 of the Lens Opacities Classification System III (LOCS-3) grading scale - Patients underwent phacoemulsification and bilateral implantation of IOLs [trifocal diffractive, bifocal hybrid (diffractive - refractive) or monofocal]
- Fluency in written and verbal Greek language
- No severe cognitive impairment
Who cannot join
- Αstigmatism >1.00 diopters
- Glaucoma
- Intraocular pressure-lowering medications
- Corneal pathology
- Fundus pathology
- Diabetes mellitus
Show all 11Show fewer
- Autoimmune diseases
- Former incisional eye surgery
- Posterior capsule rupture or lens misalignment
- Neurological, psychiatric or mental diseases that interfere with visual acuity and reading process
- Inability to understand the objectives of the study
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: Evaluation of the Impact of Light Intensity and Light Temperature on the Efficacy of Presbyopic Corrections With Bilateral Implantation of Multifocal Intraocular Lenses in a Series of Activities of Daily Living
Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and light temperature) for 10 activities of daily living (ADLs) that require near or intermediate vision acuity in a validated ADL simulation framework for a sample of patients who underwent presbyopic correction with bilateral multifocal intraocular lenses (IOLs) implantation, and to compare their capacity to perform ADLs (ADL scores) between three study groups (SG): SG1. patients implanted bilaterally with trifocal diffractive IOLs, SG2. patients implanted bilaterally with bifocal hybrid (diffractive-refractive) IOLs, SG3. patients implanted bilaterally with monofocal IOLs
Read the detailed description
Patients who underwent presbyopic correction with bilateral implantation of multifocal IOLs are supposed to have sufficient uncorrected vision capacity for ADLs that require near (ie. book reading) or intermediate (ie. reading in a computer screen) vision acuity. However, it is known that light intensity and light temperature has a great impact on near/intermediate vision capacity, but also patients that have been implanted with multifocal IOLs are most likely to present completely different lighting needs than patients with their own crystalline lenses.
Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and light temperature) for 10 ADLs that require near or intermediate vision acuity in a validated ADL simulation framework for a sample of patients who underwent presbyopic correction with bilateral multifocal IOLs implantation, and to compare their capacity to perform the ADLs (ADL scores) in 9 different lighting combinations (combinations of light intensity and light temperature) between three study groups: SG1. patients implanted bilaterally with trifocal diffractive IOLs, SG2. patients implanted bilaterally with bifocal hybrid (diffractive-refractive) IOLs, SG3. patients implanted bilaterally with monofocal IOLs
The study is conducted in an experimental facility in a hospital room with a dimension of 6.87 × 2.9 × 3 m (depth × width × height) and flat white surface walls (reflectance: 70%). Αn advanced light diffusion system has been installed, which consists of four linear LED luminaires producing low glare (unified glare rating (UGR) < 19). Light intensity (dimming / in foot candles - fc) and light temperature (white tuning / (in Kelvins - K) have been adjusted using the Casambi wireless control application (Casambi Technologies Oy Inc., Espoo, Finland), which uses integrated Bluetooth mesh technology and secures maximal uniformity at different user-defined lighting settings. The four LED luminaires have been mounted on the ceiling. The exact luminaire positioning and the amount of the provided luminous flux have been defined using the RELUX light simulation tool (version 2021.1.1.0) (Relux Informatik AG, Münchenstein, Switzerland) prior to the installation. The confirmation of illuminance and on-site adjustments have been confirmed with the Extech Lux Meter EA30 (Extech Instruments Corporation, Nashua, NH, United States). As regards photometric properties derived from lighting laboratory photometric measurements, the correlated color temperature (CCT) of the luminaires ranges between 2700 K and 6500 K, emitting a maximum luminous flux of 10,626 lm and 11,508 lm, respectively. The exact radiant flux P(λ) emitted from the selected light sources has been measured using a Konica Minolta CL-500A spectrum meter for the wavelength range of 380-780 nm using a step of 1 nm. The power of each luminaire is 106 W, resulting in luminous efficacy of 100.2 lm/W and 108.6 lm/W for 2700 K and 6500 K, respectively. The color rendering index (CRI) is 84. The wireless dimming control system enables dimming from 0% to 100% and vice versa.
The 9 lighting combinations (light intensity, light temperature) 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
In specific, patients address the following ten ADLs:
- 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).
Test-retest reliability will be assessed by calculating intraclass correlation coefficients (ICCs) for all ADLs at the nine combinations of light conditions in two different visits with an average 15-day time window to prevent memory effect.
- Conditions
- Presbyopia, Near Vision, Reading, Daily Activities, Multifocal Intraocular Lens, Cataract
- Being tested
- ADL performance
- Keywords
- activities of daily living, presbyopia, light temperature, light intensity, multifocal intraocular lens
- Medical subject headings
- Presbyopia, Myopia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADL performanceOther
ADL performance
All study groups address the following 10 ADL tasks in 9 different combinations of light temperature and light intensity in order possible differences to be revealed among the study 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 |
|---|---|---|
| SG1 - Trifocal Group | Patients implanted bilaterally with trifocal diffractive IOLs Receives: Other: ADL performance | |
| SG2 - Bifocal Group | Patients implanted bilaterally with bifocal hybrid (diffractive - refractive) IOLs Receives: Other: ADL performance | |
| SG3 - Monofocal Group | Patients implanted bilaterally with monofocal IOLs 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 (5)
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
Subjective preference of lighting combination
Patients are asked to choose the most preferable combination of light intensity and light temperature among the 9 different combinations for the most comfortable performance in ADLs
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 posted3 May 2022
- Study start15 Sep 2021
- Primary completion15 Jul 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 75 participants (actual)
- 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, Study chair, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359380
- Sponsor's protocol ID
- ES1/Th1/08-02-2018
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2022
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Labiris G, Panagiotopoulou EK, Ntonti P. Development and Validation of a Lighting Facility for the Objective Assessment of the Visual Performance of Presbyopic Patients in a Series of Activities of Daily Living. Cureus. 2022 Apr 28;14(4):e24548. doi: 10.7759/cureus.24548. eCollection 2022 Apr.
PubMed 35651385Labiris G, Panagiotopoulou EK, Taliantzis S, Perente A, Delibasis K, Doulos LT. Lighting Standards Revisited: Introduction of a Mathematical Model for the Assessment of the Impact of Illuminance on Visual Acuity. Clin Ophthalmol. 2021 Nov 28;15:4553-4564. doi: 10.2147/OPTH.S326139. eCollection 2021.
PubMed 34866900Labiris G, Panagiotopoulou EK, Duzha E, Tzinava M, Perente A, Konstantinidis A, Delibasis K. Development and Validation of a Web-Based Reading Test for Normal and Low Vision Patients. Clin Ophthalmol. 2021 Sep 22;15:3915-3929. doi: 10.2147/OPTH.S314943. eCollection 2021.
PubMed 34588763
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Light Intensity and Light Temperature on the Efficacy of Presbyopic Corrections With Bilateral Implantation of Multifocal Intraocular Lenses in a Series of Activities of Daily Living
- ClinicalTrials.gov ID
- NCT05359380
- Acronym / sponsor ID
- ES1/Th1/08-02-2018
- Conditions
- Presbyopia, Near Vision, Reading, Daily Activities, Multifocal Intraocular Lens, Cataract
- Keywords
- activities of daily living, presbyopia, light temperature, light intensity, multifocal intraocular lens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 3 May 2022 (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 to identify the optimal task lighting conditions (in terms of light intensity and light temperature) for 10 activities of daily living (ADLs) that require near or intermediate vision acuity in a validated ADL simulation framework for a sample of patients who underwent presbyopic correction with bilateral multifocal intraocular lenses (IOLs) implantation, and to compare their capacity to perform ADLs (ADL scores) between three study groups (SG): SG1. patients implanted bilaterally with trifocal diffractive IOLs, SG2. patients implanted bilaterally with bifocal hybrid (diffractive-refractive) IOLs, SG3. patients implanted bilaterally with monofocal IOLs
Detailed description
Patients who underwent presbyopic correction with bilateral implantation of multifocal IOLs are supposed to have sufficient uncorrected vision capacity for ADLs that require near (ie. book reading) or intermediate (ie. reading in a computer screen) vision acuity. However, it is known that light intensity and light temperature has a great impact on near/intermediate vision capacity, but also patients that have been implanted with multifocal IOLs are most likely to present completely different lighting needs than patients with their own crystalline lenses.
Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and light temperature) for 10 ADLs that require near or intermediate vision acuity in a validated ADL simulation framework for a sample of patients who underwent presbyopic correction with bilateral multifocal IOLs implantation, and to compare their capacity to perform the ADLs (ADL scores) in 9 different lighting combinations (combinations of light intensity and light temperature) between three study groups: SG1. patients implanted bilaterally with trifocal diffractive IOLs, SG2. patients implanted bilaterally with bifocal hybrid (diffractive-refractive) IOLs, SG3. patients implanted bilaterally with monofocal IOLs
The study is conducted in an experimental facility in a hospital room with a dimension of 6.87 × 2.9 × 3 m (depth × width × height) and flat white surface walls (reflectance: 70%). Αn advanced light diffusion system has been installed, which consists of four linear LED luminaires producing low glare (unified glare rating (UGR) < 19). Light intensity (dimming / in foot candles - fc) and light temperature (white tuning / (in Kelvins - K) have been adjusted using the Casambi wireless control application (Casambi Technologies Oy Inc., Espoo, Finland), which uses integrated Bluetooth mesh technology and secures maximal uniformity at different user-defined lighting settings. The four LED luminaires have been mounted on the ceiling. The exact luminaire positioning and the amount of the provided luminous flux have been defined using the RELUX light simulation tool (version 2021.1.1.0) (Relux Informatik AG, Münchenstein, Switzerland) prior to the installation. The confirmation of illuminance and on-site adjustments have been confirmed with the Extech Lux Meter EA30 (Extech Instruments Corporation, Nashua, NH, United States). As regards photometric properties derived from lighting laboratory photometric measurements, the correlated color temperature (CCT) of the luminaires ranges between 2700 K and 6500 K, emitting a maximum luminous flux of 10,626 lm and 11,508 lm, respectively. The exact radiant flux P(λ) emitted from the selected light sources has been measured using a Konica Minolta CL-500A spectrum meter for the wavelength range of 380-780 nm using a step of 1 nm. The power of each luminaire is 106 W, resulting in luminous efficacy of 100.2 lm/W and 108.6 lm/W for 2700 K and 6500 K, respectively. The color rendering index (CRI) is 84. The wireless dimming control system enables dimming from 0% to 100% and vice versa.
The 9 lighting combinations (light intensity, light temperature) 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
In specific, patients address the following ten ADLs:
- 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).
Test-retest reliability will be assessed by calculating intraclass correlation coefficients (ICCs) for all ADLs at the nine combinations of light conditions in two different visits with an average 15-day time window to prevent memory effect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SG1 - Trifocal Group | – | Other: ADL performancePatients implanted bilaterally with trifocal diffractive IOLs |
| SG2 - Bifocal Group | – | Other: ADL performancePatients implanted bilaterally with bifocal hybrid (diffractive - refractive) IOLs |
| SG3 - Monofocal Group | – | Other: ADL performancePatients implanted bilaterally with monofocal IOLs |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent phacoemulsification and bilateral implantation of IOLs [SG1: trifocal diffractive IOL, SG2: bifocal hybrid (diffractive - refractive) IOL, SG3: monofocal IOL]
Key inclusion criteria (4 listed)
- Age older than 18 years old
- Diagnosis of senile cataract either stage 2 or 3 of the Lens Opacities Classification System III (LOCS-3) grading scale - Patients underwent phacoemulsification and bilateral implantation of IOLs [trifocal diffractive, bifocal hybrid (diffractive - refractive) or monofocal]
- Fluency in written and verbal Greek language
- No severe cognitive impairment
Key exclusion criteria (11 listed)
- Αstigmatism >1.00 diopters
- Glaucoma
- Intraocular pressure-lowering medications
- Corneal pathology
- Fundus pathology
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 performanceADL performance All study groups address the following 10 ADL tasks in 9 different combinations of light temperature and light intensity in order possible differences to be revealed among the study 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 | SG1 - Trifocal Group, SG2 - Bifocal Group, SG3 - Monofocal Group |
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]
5 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
Subjective preference of lighting combination
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 24 Apr 2023.
- Background: PubMed 35651385Labiris G, Panagiotopoulou EK, Ntonti P. Development and Validation of a Lighting Facility for the Objective Assessment of the Visual Performance of Presbyopic Patients in a Series of Activities of Daily Living. Cureus. 2022 Apr 28;14(4):e24548. doi: 10.7759/cureus.24548. eCollection 2022 Apr.
- Background: PubMed 34866900Labiris G, Panagiotopoulou EK, Taliantzis S, Perente A, Delibasis K, Doulos LT. Lighting Standards Revisited: Introduction of a Mathematical Model for the Assessment of the Impact of Illuminance on Visual Acuity. Clin Ophthalmol. 2021 Nov 28;15:4553-4564. doi: 10.2147/OPTH.S326139. eCollection 2021.
- Background: PubMed 34588763Labiris G, Panagiotopoulou EK, Duzha E, Tzinava M, Perente A, Konstantinidis A, Delibasis K. Development and Validation of a Web-Based Reading Test for Normal and Low Vision Patients. Clin Ophthalmol. 2021 Sep 22;15:3915-3929. doi: 10.2147/OPTH.S314943. eCollection 2021.
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
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 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 4 inclusion and 11 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 24 Apr 2023. 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?
On the ClinicalTrials.gov record for NCT05359380, which also lists 3 linked publications.
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 24 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.