Comparative Functional Vision Outcomes: DAILIES TOTAL1 Toric vs. Spherical Lenses in Asian Astigmatic Patients

NCT06230263 | Unknown

• 1 other identifier: #IIT89779909
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Comparative Effectiveness Research

Keywords

Astigmatism; Toric Contact Lenses; Contact Lens Satisfaction; Digital Device Usage

Outcome Measures

Primary Outcomes (1)

• Near high-contrast visual acuity (40cm)

  Assess near high-contrast visual acuity (40cm) using EyeChart PRO on an iPad.

  Day 4, Day 8

Secondary Outcomes (6)

• Reading Acuity

  Day 4, Day 8

• Critical Print Size

  Day 4, Day 8

• Maximum Reading Speed

  Day 4, Day 8

• Reading Accessibility Index

  Day 4, Day 8

• Near Activity Visual Questionnaire (NAVQ)

  Day 4, Day 8

Study Arms (2)

DAILIES TOTAL1® for Astigmatism

EXPERIMENTAL

DAILIES TOTAL1® for Astigmatism

Diagnostic Test: Visual acuity test

Spherical Contact Lenses

ACTIVE COMPARATOR

DAILIES TOTAL1® Spherical Contact Lenses

Diagnostic Test: Visual acuity test

Interventions

Visual acuity test DIAGNOSTIC_TEST

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).

Also known as: Reading acuity test, Near Activity Visual Questionnaire

DAILIES TOTAL1® for Astigmatism; Spherical Contact Lenses

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mopsy Research: lead

Study Sites (1)

Mopsy Research

Hong Kong, 0000, Hong Kong

RECRUITING

Related Publications (14)

• 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.

  PMID: 21178696 BACKGROUND

• Morgan 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.

  PMID: 23392302 BACKGROUND

• Efron 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.

  PMID: 26101823 BACKGROUND

• Richdale 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.

  PMID: 18049362 BACKGROUND

• Cox 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.

  PMID: 28945646 BACKGROUND

• Woods 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.

  PMID: 19675462 BACKGROUND

• Morgan 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.

  PMID: 16189492 BACKGROUND

• Calabrese 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.

  PMID: 29351351 BACKGROUND

• GRIZZLE JE. THE TWO-PERIOD CHANGE-OVER DESIGN AN ITS USE IN CLINICAL TRIALS. Biometrics. 1965 Jun;21:467-80. No abstract available.

  PMID: 14338679 BACKGROUND

• Buckhurst 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.

  PMID: 22078121 BACKGROUND

• Thompson 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.

  PMID: 2697559 BACKGROUND

• Bhaskaran 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.

  PMID: 35813797 BACKGROUND

• Hazari 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.

  PMID: 32985378 BACKGROUND

• Zhang 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.

  PMID: 23434538 BACKGROUND

Related Links

• Howard, J. (2016, July 29). Americans Devote More than 10 Hours a Day to Screen Time, and Growing.

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• MANKI CHAN

  Mopsy Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MANKI CHAN

CONTACT

+85225231883; mank@live.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization: Generate a random list of 39 labels ("A" for DAILIES TOTAL1® for Astigmatism, "B" for Spherical Contact Lenses) using a computer. Randomize the list order and apply matching coded stickers to lens packages. A designated unmasked examiner has exclusive access to the decoding key and does not partake in direct participant interaction or data handling. Visit 1: Confirm participant eligibility, then the unmasked examiner uses the random list to provide the coded lens package to the masked examiner. The masked examiner fits the participant with the first set of lenses, unaware of the type. Visit 3: The unmasked examiner repeats Visit 1's procedure for the second set of lenses. Blinded study conditions are maintained as the masked examiner fits the second pair of lenses. End of Study: The unmasked examiner decodes the lens order for data analysis. This method ensures a double-blind crossover design, minimizing bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 30, 2024
• Study Start: December 30, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)