Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization

NCT06527274 | Active Not Recruiting DMC

• 1 other identifier: 2024-5133
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to gain a better understanding of the retinal vascular changes that occur in response to the optical effect of a myopic defocus daily disposable soft contact lens (MDSL) in a group of healthy young myopic adults (18-35 years; myopia -1.00D to -4.00D; all genders). It will also learn about the acceptance of this visual correction modality compared to regular contact lenses. The main questions to be answered are:

• To evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus after one week of MDSL wear.
• To evaluate changes in choroidal thickness at the macular level after one week of MDSL wear.
• To evaluate the visual comfort provided by this MDSL design using a questionnaire. Researchers will compare the MDSL to a daily disposable single vision soft lens (SVSL) used to correct myopia to determine if the addition of a defocus area makes a difference in the retinal response to the visual signal. Participants will be required to
• Wear both MDSL and SVSL for one week each, in a random order.
• Read letters to measure visual acuity
• Have a deep scan of their retina with an optical coherence tomography (OCT) device
• Rate the comfort and vision provided by both devices using a questionnaire.

Conditions

Nearsightedness

Keywords

myopia; retinal vasculature; choroidal thickness

Outcome Measures

Primary Outcomes (1)

• Measurement of Retinal blood vessel density measured by Triton OCT-A

  The TRITON angiographic optical coherence tomograph will be used in this research project. OCT-A is a non-invasive angiography that enables changes in retinal vascularization to be observed. This is achieved by analyzing the movement of erythrocytes in blood vessels using a series of B-scans. Retinal vessel density will be measured at the macular area and at the optic nerve head. (2 scans)

  Measurement done at baseline and after 1 week of contact lens wear

Other Outcomes (1)

• Evaluation of the choroidal thickness at the macular area

  Measurement done at baseline and after 1 week of contact lens wear

Study Arms (2)

Myopic defocus soft lens design (MDSL)

EXPERIMENTAL

This arm involves the wear of a daily disposable soft contact lens (nesofilcon A) designed with a myopic defocus zone. This is a 14.2mm total diameter lens with a 4.2mm central zone for distance vision correction. This is followed by an abrupt transition zone of 1.2mm with no optical power. Then a higher convex power zone covers the surface to the edge of the optical zone (8mm). The rest of the lens (up to 14.2 mmOAD) supports the lens on the eye surface and has no power nor refractive effect. The power of the add area is calibrated to the central power to achieve a net add power of +5D. For example: -1.00D central power is surrounded by a +6D convex area; -2D is surrounded by a +7D area, and so on.)

Device: Experimental: Myopic defocus soft lens design (MDSL)

Single vision soft lens design (SVSL)

ACTIVE COMPARATOR

This arm involves the wear of a daily disposable soft contact lens (nesofilcon A) designed as a regular optical device to compensate for refractive error. In the case of this study, this lens will be made available from -1.00D to -4.00D. This lens is already in regular use in the US (K113703) and Canadian markets. Its design includes a central optical zone of 8mm that is powered to correct distance vision. The rest of the lens is supported on the ocular surface and has no power.

Device: Active Comparator: Single vision soft lens design (SVSL

Interventions

Experimental: Myopic defocus soft lens design (MDSL) DEVICE

An optical device designed to provide a myopic defocus to control myopia progression

Myopic defocus soft lens design (MDSL)

Active Comparator: Single vision soft lens design (SVSL DEVICE

An optical device designed to correct refractive error like myopia

Single vision soft lens design (SVSL)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• · Astigmatism ≤ 1.00 D
• Myopia between -0.50 and -4.00D
• Aged between 18 and 35
• Binocular acuity of 6/6 or better

You may not qualify if:

• · Recent intake (\< 3 months) of medication affecting blood pressure (e.g. hypotensive, anovulant, CNS stimulant, etc.).
• Corneal dystrophy or irregularity
• Use of topical ocular medications
• Smoking (tobacco or marijuana)
• Have contraindications to wearing soft contact lenses
• Being currently under myopia control treatment or had been under control in the last 3 months
• Being pregnant or breast-feeding
• History of refractive surgery
• Addiction to drugs or alcohol

Sponsors & Collaborators

• Université de Montréal: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Universite de Montreal

Montreal, Quebec, H3T1P1, Canada

Location

Related Publications (9)

• Agawa T, Miura M, Ikuno Y, Makita S, Fabritius T, Iwasaki T, Goto H, Nishida K, Yasuno Y. Choroidal thickness measurement in healthy Japanese subjects by three-dimensional high-penetration optical coherence tomography. Graefes Arch Clin Exp Ophthalmol. 2011 Oct;249(10):1485-92. doi: 10.1007/s00417-011-1708-7. Epub 2011 May 10.

  PMID: 21556938 BACKGROUND

• Harb E, Hyman L, Gwiazda J, Marsh-Tootle W, Zhang Q, Hou W, Norton TT, Weise K, Dirkes K, Zangwill LM; COMET Study Group. Choroidal Thickness Profiles in Myopic Eyes of Young Adults in the Correction of Myopia Evaluation Trial Cohort. Am J Ophthalmol. 2015 Jul;160(1):62-71.e2. doi: 10.1016/j.ajo.2015.04.018. Epub 2015 Apr 18.

  PMID: 25896460 BACKGROUND

• Ostrin LA, Harb E, Nickla DL, Read SA, Alonso-Caneiro D, Schroedl F, Kaser-Eichberger A, Zhou X, Wildsoet CF. IMI-The Dynamic Choroid: New Insights, Challenges, and Potential Significance for Human Myopia. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):4. doi: 10.1167/iovs.64.6.4.

  PMID: 37126359 BACKGROUND

• Chiang ST, Phillips JR, Backhouse S. Effect of retinal image defocus on the thickness of the human choroid. Ophthalmic Physiol Opt. 2015 Jul;35(4):405-13. doi: 10.1111/opo.12218. Epub 2015 May 24.

  PMID: 26010292 BACKGROUND

• Wang D, Chun RK, Liu M, Lee RP, Sun Y, Zhang T, Lam C, Liu Q, To CH. Optical Defocus Rapidly Changes Choroidal Thickness in Schoolchildren. PLoS One. 2016 Aug 18;11(8):e0161535. doi: 10.1371/journal.pone.0161535. eCollection 2016.

  PMID: 27537606 BACKGROUND

• Breher K, Garcia Garcia M, Ohlendorf A, Wahl S. The effect of the optical design of multifocal contact lenses on choroidal thickness. PLoS One. 2018 Nov 16;13(11):e0207637. doi: 10.1371/journal.pone.0207637. eCollection 2018.

  PMID: 30444900 BACKGROUND

• Campbell JP, Zhang M, Hwang TS, Bailey ST, Wilson DJ, Jia Y, Huang D. Detailed Vascular Anatomy of the Human Retina by Projection-Resolved Optical Coherence Tomography Angiography. Sci Rep. 2017 Feb 10;7:42201. doi: 10.1038/srep42201.

  PMID: 28186181 BACKGROUND

• Swiatczak B, Schaeffel F, Calzetti G. Imposed positive defocus changes choroidal blood flow in young human subjects. Graefes Arch Clin Exp Ophthalmol. 2023 Jan;261(1):115-125. doi: 10.1007/s00417-022-05842-z. Epub 2022 Sep 29.

  PMID: 36171460 BACKGROUND

• Wang E, Zhao X, Yang J, Chen Y. Visualization of deep choroidal vasculatures and measurement of choroidal vascular density: a swept-source optical coherence tomography angiography approach. BMC Ophthalmol. 2020 Aug 5;20(1):321. doi: 10.1186/s12886-020-01591-x.

  PMID: 32758186 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Langis Michaud, OD MS

  Universite de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The lenses used in this study are daily disposable. This means that for each type of lens worn, participants will receive 7 lenses of each type. Lenses will be delivered one type at a time for the next week. The lenses will be packaged with a neutral label with a lot number. It is impossible for the participant to know which type this lot number corresponds to. Therefore, they do not know what type of lens they will receive.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, crossover masked study. Participants are randomly assigned to wear one type of soft lens for one week, then washed out for a few days, and then the second type of soft lens for the same period of time. Participants are masked to the type of lens provided

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 30, 2024
• Study Start: June 25, 2024
• Primary Completion: January 31, 2025
• Study Completion: March 30, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)