Comparative Effectiveness ResearchNCT06230263
Comparative Functional Vision Outcomes: DAILIES TOTAL1 Toric vs. Spherical Lenses in Asian Astigmatic Patients
A study testing Visual acuity test in people with Comparative Effectiveness Research, run by Mopsy Research at 1 site in Hong Kong.
Trial summary
The goal of this comparative clinical trial is to assess the effectiveness of DAILIES TOTAL1 Toric Contact Lenses compared to Spherical Equivalent Contact Lenses in improving the functional vision of astigmatic patients, with a particular focus on Asian individuals who frequently use digital devices. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Comparative Effectiveness Research
- What is being tested?
- Visual acuity test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Dec 2023to 1 Apr 2024
- Phase
- Interventional
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-identified as Asian, confirmed through both self-report and observation by the Principal Investigator (PI).
- Age between 18 and 39 years.
- Vertexed corrected sphere power ranging from -0.50 to -6.00 diopters (D).
- Vertexed refractive cylinder power ranging from -0.75 to -1.50 diopters (D).
- Best corrected visual acuity of 20/25 or better in each eye.
- Habitual soft contact lens wear for at least 6 months and must be successfully fitted with both DT1 Spherical and Toric contact lenses.
Who cannot join
- Any history of ocular pathology or surgery.
- Presence of active ocular infection or clinically significant ocular inflammation.
- Presence of any significant binocular vision abnormalities.
- Use of gas-permeable contact lenses within 3 months prior to the study.
- Pregnancy or lactation, confirmed by self-report.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Mopsy Research
Hong Kong, 0000
MANKI CHAN, +85225231883, mank@live.hk
About this study
Official title: A Comparative Study on Functional Vision in Astigmatic Patients: DAILIES TOTAL1 Toric Contact Lenses vs. Spherical Equivalent Contact Lenses in Asian Eyes
The goal of this comparative clinical trial is to assess the effectiveness of DAILIES TOTAL1 Toric Contact Lenses compared to Spherical Equivalent Contact Lenses in improving the functional vision of astigmatic patients, with a particular focus on Asian individuals who frequently use digital devices.
The main questions it aims to answer are:
Read more
How do DAILIES TOTAL1 Toric Contact Lenses affect the quality of vision in daily activities, especially when using digital screens, compared to Spherical Equivalent Contact Lenses?
What is the level of comfort and overall satisfaction among participants using DAILIES TOTAL1 Toric Contact Lenses versus those using Spherical Equivalent Contact Lenses?
Participants will be asked to wear both types of contact lenses for a specified period. During this time, they will perform various tasks involving digital screens. Their vision quality and comfort levels will be monitored and recorded. They will also be asked to report their satisfaction with each type of lens and any differences in their experience with screen use.
Read the detailed description
Background:
In today's digital age, individuals spend a significant amount of time using digital devices [1]. This is notably challenging for individuals with astigmatism, a condition that can impair visual acuity when using these devices [2]. Despite the prevalence of astigmatism, toric contact lens technology, which can potentially improve visual acuity for these individuals, remains underused [3][4]. Many eye care practitioners opt for spherical lenses due to perceived complexities of fitting and considerations of cost-effectiveness [5][6].
DAILIES TOTAL1® for Astigmatism contact lenses, the first and only daily disposable Water Gradient toric contact lenses, can potentially address this issue. These lenses represent a significant innovation in toric contact lens technology, offering a unique combination of breathability and exceptional comfort. The lenses utilize Water Gradient Technology, creating a gradual transition in water content from the core to the surface of the lens, with the water content approaching 100% at the lens surface. This technology enables these lenses to offer a combination of high breathability and exceptional comfort.
Unmet Medical Need:
Although toric lenses, including DAILIES TOTAL1® for Astigmatism, have been shown to improve visual acuity in astigmatic patients, their impact on real-world visual performance, particularly when using digital devices, is less understood [1]. Additionally, while many practitioners gravitate towards spherical lenses, astigmatic patients could greatly benefit from the comfort and visual acuity provided by DAILIES TOTAL1® for Astigmatism contact lenses.
Gaining insights into the real-world visual performance of astigmatic patients when using DAILIES TOTAL1® for Astigmatism contact lenses could provide valuable information to eye care practitioners and patients. This could potentially encourage the broader adoption of DAILIES TOTAL1® for Astigmatism contact lenses, improving the visual experience for astigmatic patients and addressing an unmet medical need.
Scientific Rationale:
Previous clinical studies have demonstrated the benefits of toric contact lenses in improving visual acuity in astigmatic patients[5]. However, these studies primarily used traditional high-contrast, high-luminance visual acuity testing, which may not accurately reflect the visual demands of real-world tasks, especially those involving digital devices [7][8].
DAILIES TOTAL1® for Astigmatism contact lenses stand out due to their unique Water Gradient Technology and Precision Balance 8|4® Lens Design. The gradual transition in water content from the core to the surface of the lens, with the water content approaching 100% at the lens surface, enables a combination of high breathability and exceptional comfort. The lens design ensures a quick and stable fit, with 99% first-lens fit success. Additionally, these lenses feature SmarTears® Technology, which releases an ingredient found naturally in tears to stabilize the lipid layer of the tear film, further promoting comfort for the wearer.
This study seeks to extend previous findings by evaluating the impact of DAILIES TOTAL1® for Astigmatism Contact Lenses on subjective and objective visual performance outcomes in astigmatic patients using digital devices [9]. This will involve the use of advanced digital real-world and patient-reported outcome tools, providing a comprehensive evaluation of vision beyond acuity alone. The goal is to ascertain whether the unique benefits of DAILIES TOTAL1® for Astigmatism Contact Lenses translate to improved functional vision and overall satisfaction for astigmatic patients.
Objective:
This study aims to assess the impact of DAILIES TOTAL1® for Astigmatism Contact Lenses on the functional vision of astigmatic patients as compared to DAILIES TOTAL1® Spherical Contact Lenses, using digital real-world and patient-reported outcome tools in Asian Eyes.
Hypothesis:
DAILIES TOTAL1® for Astigmatism Contact Lenses will improve both subjective and objective visual performance in astigmatic patients using digital devices compared to DAILIES TOTAL1® Spherical Contact Lenses in Asian Eyes.
- Conditions
- Comparative Effectiveness Research
- Being tested
- Visual acuity test
- Keywords
- Astigmatism, Toric Contact Lenses, Contact Lens Satisfaction, Digital Device Usage
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual acuity testDiagnostic test
Also called Reading acuity test, Near Activity Visual Questionnaire
Assess near high-contrast visual acuity (40cm) using EyeChart PRO on an iPad.
Use the MNREAD app to measure:
Reading Acuity: Smallest font size read without errors. Critical Print Size: Smallest font size for peak reading speed. Maximum Reading Speed: Time to read comfortable font size, in words per minute. Reading Accessibility Index: Single metric summarizing visual access to print. Assess near visual function with the Near Activity Visual Questionnaire.
Evaluate distance visual acuity, both high and low contrast, using logMAR and the E-ETDRS (NIDEK SC-2000).
| Study group | Role | What they receive |
|---|---|---|
| DAILIES TOTAL1® for Astigmatism | Experimental | DAILIES TOTAL1® for Astigmatism Receives: Diagnostic Test: Visual acuity test |
| Spherical Contact Lenses | Active comparator | DAILIES TOTAL1® Spherical Contact Lenses Receives: Diagnostic Test: Visual acuity test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near high-contrast visual acuity (40cm)
Assess near high-contrast visual acuity (40cm) using EyeChart PRO on an iPad.
Measured: Day 4, Day 8
Secondary outcomes (6)
Reading Acuity
Reading Acuity refers to the smallest font size at which text can be read without errors.
The MNREAD app will be used to determine the Reading Acuity, which will be reported in units of point size (pt).
Measured: Day 4, Day 8
Critical Print Size
Critical Print Size is the smallest font size at which the individual achieves their peak reading speed.
The MNREAD app will measure the Critical Print Size and report it in point size (pt).
Measured: Day 4, Day 8
Maximum Reading Speed
Maximum Reading Speed is the fastest rate at which text in a comfortable font size can be read.
The MNREAD app will record the Maximum Reading Speed in words per minute (wpm).
Measured: Day 4, Day 8
Reading Accessibility Index
Reading Accessibility Index is a single metric that summarizes an individual's visual access to print.
The MNREAD app will calculate the Reading Accessibility Index based on a combination of the above measures. The index will be dimensionless but will take into account the variations in font size (pt) and reading speed (wpm) to provide a standardized score reflecting overall reading accessibility.
Measured: Day 4, Day 8
Near Activity Visual Questionnaire (NAVQ)
The Near Activity Visual Questionnaire (NAVQ) is used to assess the near visual function, which includes the ability to perform activities that require close-up vision.
Participants will respond to the NAVQ, which will be scored on a scale ranging from 0 to 3 for each item.
- Scale Range: The scale ranges from 0 to 3, where:
- '0' indicates no difficulty,
- '1' indicates mild difficulty,
- '2' indicates moderate difficulty,
- '3' indicates extreme difficulty.
The total NAVQ score is calculated by summing the individual scores for each item. The minimum score is '0', which would indicate no difficulty with near visual tasks, and the maximum possible score is dependent on the number of items in the questionnaire.
Lower Scores Represent**: A better outcome, with less difficulty in near visual tasks.
Higher Scores Represent**: A worse outcome, with greater difficulty in near visual tasks.
Measured: Day 4, Day 8
Distance visual acuity
Evaluate distance visual acuity, both high and low contrast, using logMAR and the E-ETDRS (NIDEK SC-2000).
Measured: Day 4, Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start30 Dec 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Comparative Effectiveness ResearchStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will follow a double-masked randomized crossover design \[10\], where participants will be fitted with DAILIES TOTAL1® for Astigmatism and DAILIES TOTAL1® Spherical Contact Lenses in a randomized order. Each participant will use both types of lenses over different periods.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mopsy Research
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- MANKI CHAN, Principal investigator, Mopsy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230263
- Sponsor's protocol ID
- #IIT89779909
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Young G, Sulley A, Hunt C. Prevalence of astigmatism in relation to soft contact lens fitting. Eye Contact Lens. 2011 Jan;37(1):20-5. doi: 10.1097/ICL.0b013e3182048fb9.
PubMed 21178696Morgan PB, Efron N, Woods CA; International Contact Lens Prescribing Survey Consortium. An international survey of toric contact lens prescribing. Eye Contact Lens. 2013 Mar;39(2):132-7. doi: 10.1097/ICL.0b013e318268612c.
PubMed 23392302Efron N, Nichols JJ, Woods CA, Morgan PB. Trends in US Contact Lens Prescribing 2002 to 2014. Optom Vis Sci. 2015 Jul;92(7):758-67. doi: 10.1097/OPX.0000000000000623.
PubMed 26101823Richdale K, Berntsen DA, Mack CJ, Merchea MM, Barr JT. Visual acuity with spherical and toric soft contact lenses in low- to moderate-astigmatic eyes. Optom Vis Sci. 2007 Oct;84(10):969-75. doi: 10.1097/OPX.0b013e318157c6dc.
PubMed 18049362Cox SM, Berntsen DA, Bickle KM, Mathew JH, Powell DR, Little BK, Lorenz KO, Nichols JJ. Efficacy of Toric Contact Lenses in Fitting and Patient-Reported Outcomes in Contact Lens Wearers. Eye Contact Lens. 2018 Sep;44 Suppl 1:S296-S299. doi: 10.1097/ICL.0000000000000418.
PubMed 28945646Woods J, Woods CA, Fonn D. Early symptomatic presbyopes--what correction modality works best? Eye Contact Lens. 2009 Sep;35(5):221-6. doi: 10.1097/ICL.0b013e3181b5003b.
PubMed 19675462Morgan PB, Efron SE, Efron N, Hill EA. Inefficacy of aspheric soft contact lenses for the correction of low levels of astigmatism. Optom Vis Sci. 2005 Sep;82(9):823-8. doi: 10.1097/01.opx.0000177792.62460.58.
PubMed 16189492Calabrese A, To L, He Y, Berkholtz E, Rafian P, Legge GE. Comparing performance on the MNREAD iPad application with the MNREAD acuity chart. J Vis. 2018 Jan 1;18(1):8. doi: 10.1167/18.1.8.
PubMed 29351351GRIZZLE JE. THE TWO-PERIOD CHANGE-OVER DESIGN AN ITS USE IN CLINICAL TRIALS. Biometrics. 1965 Jun;21:467-80. No abstract available.
PubMed 14338679Buckhurst PJ, Wolffsohn JS, Gupta N, Naroo SA, Davies LN, Shah S. Development of a questionnaire to assess the relative subjective benefits of presbyopia correction. J Cataract Refract Surg. 2012 Jan;38(1):74-9. doi: 10.1016/j.jcrs.2011.07.032. Epub 2011 Nov 10.
PubMed 22078121Thompson KA, Soler AP, Smith RM, Jarett L. Intranuclear localization of insulin in rat hepatoma cells: insulin/matrix association. Eur J Cell Biol. 1989 Dec;50(2):442-6.
PubMed 2697559Bhaskaran A, Babu M, Abhilash B, Sudhakar NA, Dixitha V. Comparison of smartphone application-based visual acuity with traditional visual acuity chart for use in tele-ophthalmology. Taiwan J Ophthalmol. 2022 May 13;12(2):155-163. doi: 10.4103/tjo.tjo_7_22. eCollection 2022 Apr-Jun.
PubMed 35813797Hazari H, Curtis R, Eden K, Hopman WM, Irrcher I, Bona MD. Validation of the visual acuity iPad app Eye Chart Pro compared to the standard Early Treatment Diabetic Retinopathy Study chart in a low-vision population. J Telemed Telecare. 2022 Oct;28(9):680-686. doi: 10.1177/1357633X20960640. Epub 2020 Sep 26.
PubMed 32985378Zhang ZT, Zhang SC, Huang XG, Liang LY. A pilot trial of the iPad tablet computer as a portable device for visual acuity testing. J Telemed Telecare. 2013 Jan;19(1):55-9. doi: 10.1177/1357633X12474964. Epub 2013 Feb 22.
PubMed 23434538
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on Functional Vision in Astigmatic Patients: DAILIES TOTAL1 Toric Contact Lenses vs. Spherical Equivalent Contact Lenses in Asian Eyes
- ClinicalTrials.gov ID
- NCT06230263
- Acronym / sponsor ID
- #IIT89779909
- Conditions
- Comparative Effectiveness Research
- Keywords
- Astigmatism, Toric Contact Lenses, Contact Lens Satisfaction, Digital Device Usage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Mopsy ResearchResearch network
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 30 Jan 2024 (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 goal of this comparative clinical trial is to assess the effectiveness of DAILIES TOTAL1 Toric Contact Lenses compared to Spherical Equivalent Contact Lenses in improving the functional vision of astigmatic patients, with a particular focus on Asian individuals who frequently use digital devices.
The main questions it aims to answer are:
How do DAILIES TOTAL1 Toric Contact Lenses affect the quality of vision in daily activities, especially when using digital screens, compared to Spherical Equivalent Contact Lenses?
What is the level of comfort and overall satisfaction among participants using DAILIES TOTAL1 Toric Contact Lenses versus those using Spherical Equivalent Contact Lenses?
Participants will be asked to wear both types of contact lenses for a specified period. During this time, they will perform various tasks involving digital screens. Their vision quality and comfort levels will be monitored and recorded. They will also be asked to report their satisfaction with each type of lens and any differences in their experience with screen use.
Detailed description
Background:
In today's digital age, individuals spend a significant amount of time using digital devices [1]. This is notably challenging for individuals with astigmatism, a condition that can impair visual acuity when using these devices [2]. Despite the prevalence of astigmatism, toric contact lens technology, which can potentially improve visual acuity for these individuals, remains underused [3][4]. Many eye care practitioners opt for spherical lenses due to perceived complexities of fitting and considerations of cost-effectiveness [5][6].
DAILIES TOTAL1® for Astigmatism contact lenses, the first and only daily disposable Water Gradient toric contact lenses, can potentially address this issue. These lenses represent a significant innovation in toric contact lens technology, offering a unique combination of breathability and exceptional comfort. The lenses utilize Water Gradient Technology, creating a gradual transition in water content from the core to the surface of the lens, with the water content approaching 100% at the lens surface. This technology enables these lenses to offer a combination of high breathability and exceptional comfort.
Unmet Medical Need:
Although toric lenses, including DAILIES TOTAL1® for Astigmatism, have been shown to improve visual acuity in astigmatic patients, their impact on real-world visual performance, particularly when using digital devices, is less understood [1]. Additionally, while many practitioners gravitate towards spherical lenses, astigmatic patients could greatly benefit from the comfort and visual acuity provided by DAILIES TOTAL1® for Astigmatism contact lenses.
Gaining insights into the real-world visual performance of astigmatic patients when using DAILIES TOTAL1® for Astigmatism contact lenses could provide valuable information to eye care practitioners and patients. This could potentially encourage the broader adoption of DAILIES TOTAL1® for Astigmatism contact lenses, improving the visual experience for astigmatic patients and addressing an unmet medical need.
Scientific Rationale:
Previous clinical studies have demonstrated the benefits of toric contact lenses in improving visual acuity in astigmatic patients[5]. However, these studies primarily used traditional high-contrast, high-luminance visual acuity testing, which may not accurately reflect the visual demands of real-world tasks, especially those involving digital devices [7][8].
DAILIES TOTAL1® for Astigmatism contact lenses stand out due to their unique Water Gradient Technology and Precision Balance 8|4® Lens Design. The gradual transition in water content from the core to the surface of the lens, with the water content approaching 100% at the lens surface, enables a combination of high breathability and exceptional comfort. The lens design ensures a quick and stable fit, with 99% first-lens fit success. Additionally, these lenses feature SmarTears® Technology, which releases an ingredient found naturally in tears to stabilize the lipid layer of the tear film, further promoting comfort for the wearer.
This study seeks to extend previous findings by evaluating the impact of DAILIES TOTAL1® for Astigmatism Contact Lenses on subjective and objective visual performance outcomes in astigmatic patients using digital devices [9]. This will involve the use of advanced digital real-world and patient-reported outcome tools, providing a comprehensive evaluation of vision beyond acuity alone. The goal is to ascertain whether the unique benefits of DAILIES TOTAL1® for Astigmatism Contact Lenses translate to improved functional vision and overall satisfaction for astigmatic patients.
Objective:
This study aims to assess the impact of DAILIES TOTAL1® for Astigmatism Contact Lenses on the functional vision of astigmatic patients as compared to DAILIES TOTAL1® Spherical Contact Lenses, using digital real-world and patient-reported outcome tools in Asian Eyes.
Hypothesis:
DAILIES TOTAL1® for Astigmatism Contact Lenses will improve both subjective and objective visual performance in astigmatic patients using digital devices compared to DAILIES TOTAL1® Spherical Contact Lenses in Asian Eyes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will follow a double-masked randomized crossover design [10], where participants will be fitted with DAILIES TOTAL1® for Astigmatism and DAILIES TOTAL1® Spherical Contact Lenses in a randomized order. Each participant will use both types of lenses over different periods.
| Arm | Type | Receives |
|---|---|---|
| DAILIES TOTAL1® for Astigmatism | Experimental | Diagnostic Test: Visual acuity testDAILIES TOTAL1® for Astigmatism |
| Spherical Contact Lenses | Active comparator | Diagnostic Test: Visual acuity testDAILIES TOTAL1® Spherical Contact Lenses |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Self-identified as Asian, confirmed through both self-report and observation by the Principal Investigator (PI).
- Age between 18 and 39 years.
- Vertexed corrected sphere power ranging from -0.50 to -6.00 diopters (D).
- Vertexed refractive cylinder power ranging from -0.75 to -1.50 diopters (D).
- Best corrected visual acuity of 20/25 or better in each eye.
Key exclusion criteria (5 listed)
- Any history of ocular pathology or surgery.
- Presence of active ocular infection or clinically significant ocular inflammation.
- Presence of any significant binocular vision abnormalities.
- Use of gas-permeable contact lenses within 3 months prior to the study.
- Pregnancy or lactation, confirmed by self-report.
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 |
|---|---|---|
| Visual acuity testAlso: Reading acuity test, Near Activity Visual QuestionnaireAssess near high-contrast visual acuity (40cm) using EyeChart PRO on an iPad. Use the MNREAD app to measure: Reading Acuity: Smallest font size read without errors. Critical Print Size: Smallest font size for peak reading speed. Maximum Reading Speed: Time to read comfortable font size, in words per minute. Reading Accessibility Index: Single metric summarizing visual access to print. Assess near visual function with the Near Activity Visual Questionnaire. Evaluate distance visual acuity, both high and low contrast, using logMAR and the E-ETDRS (NIDEK SC-2000). | Diagnostic test | DAILIES TOTAL1® for Astigmatism, Spherical Contact Lenses |
Primary outcome
Near high-contrast visual acuity (40cm)
Time frame: Day 4, Day 8
Assess near high-contrast visual acuity (40cm) using EyeChart PRO on an iPad.
6 secondary outcomes
Reading Acuity
Time frame: Day 4, Day 8
Critical Print Size
Time frame: Day 4, Day 8
Maximum Reading Speed
Time frame: Day 4, Day 8
Reading Accessibility Index
Time frame: Day 4, Day 8
Near Activity Visual Questionnaire (NAVQ)
Time frame: Day 4, Day 8
Distance visual acuity
Time frame: Day 4, Day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 21178696Young G, Sulley A, Hunt C. Prevalence of astigmatism in relation to soft contact lens fitting. Eye Contact Lens. 2011 Jan;37(1):20-5. doi: 10.1097/ICL.0b013e3182048fb9.
- Background: PubMed 23392302Morgan PB, Efron N, Woods CA; International Contact Lens Prescribing Survey Consortium. An international survey of toric contact lens prescribing. Eye Contact Lens. 2013 Mar;39(2):132-7. doi: 10.1097/ICL.0b013e318268612c.
- Background: PubMed 26101823Efron N, Nichols JJ, Woods CA, Morgan PB. Trends in US Contact Lens Prescribing 2002 to 2014. Optom Vis Sci. 2015 Jul;92(7):758-67. doi: 10.1097/OPX.0000000000000623.
- Background: PubMed 18049362Richdale K, Berntsen DA, Mack CJ, Merchea MM, Barr JT. Visual acuity with spherical and toric soft contact lenses in low- to moderate-astigmatic eyes. Optom Vis Sci. 2007 Oct;84(10):969-75. doi: 10.1097/OPX.0b013e318157c6dc.
- Background: PubMed 28945646Cox SM, Berntsen DA, Bickle KM, Mathew JH, Powell DR, Little BK, Lorenz KO, Nichols JJ. Efficacy of Toric Contact Lenses in Fitting and Patient-Reported Outcomes in Contact Lens Wearers. Eye Contact Lens. 2018 Sep;44 Suppl 1:S296-S299. doi: 10.1097/ICL.0000000000000418.
- Background: PubMed 19675462Woods J, Woods CA, Fonn D. Early symptomatic presbyopes--what correction modality works best? Eye Contact Lens. 2009 Sep;35(5):221-6. doi: 10.1097/ICL.0b013e3181b5003b.
- Background: PubMed 16189492Morgan PB, Efron SE, Efron N, Hill EA. Inefficacy of aspheric soft contact lenses for the correction of low levels of astigmatism. Optom Vis Sci. 2005 Sep;82(9):823-8. doi: 10.1097/01.opx.0000177792.62460.58.
- Background: PubMed 29351351Calabrese A, To L, He Y, Berkholtz E, Rafian P, Legge GE. Comparing performance on the MNREAD iPad application with the MNREAD acuity chart. J Vis. 2018 Jan 1;18(1):8. doi: 10.1167/18.1.8.
- Background: PubMed 14338679GRIZZLE JE. THE TWO-PERIOD CHANGE-OVER DESIGN AN ITS USE IN CLINICAL TRIALS. Biometrics. 1965 Jun;21:467-80. No abstract available.
- Background: PubMed 22078121Buckhurst PJ, Wolffsohn JS, Gupta N, Naroo SA, Davies LN, Shah S. Development of a questionnaire to assess the relative subjective benefits of presbyopia correction. J Cataract Refract Surg. 2012 Jan;38(1):74-9. doi: 10.1016/j.jcrs.2011.07.032. Epub 2011 Nov 10.
- Background: PubMed 2697559Thompson KA, Soler AP, Smith RM, Jarett L. Intranuclear localization of insulin in rat hepatoma cells: insulin/matrix association. Eur J Cell Biol. 1989 Dec;50(2):442-6.
- Background: PubMed 35813797Bhaskaran A, Babu M, Abhilash B, Sudhakar NA, Dixitha V. Comparison of smartphone application-based visual acuity with traditional visual acuity chart for use in tele-ophthalmology. Taiwan J Ophthalmol. 2022 May 13;12(2):155-163. doi: 10.4103/tjo.tjo_7_22. eCollection 2022 Apr-Jun.
- Howard, J. (2016, July 29). Americans Devote More than 10 Hours a Day to Screen Time, and Growing.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
MANKI CHAN principal investigator
Mopsy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual acuity test in people with Comparative Effectiveness Research, run by Mopsy Research at 1 site in Hong Kong.
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 6 inclusion and 5 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 30 Jan 2024. 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 Hong Kong. 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 MANKI CHAN (+85225231883, mank@live.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near high-contrast visual acuity (40cm) (time frame: Day 4, Day 8). 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 NCT06230263, which also lists 14 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 30 Jan 2024.