NearsightednessNCT06527274
Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization
A study testing Experimental: Myopic defocus soft lens design (MDSL) and Active Comparator: Single vision soft lens design (SVSL in people with Nearsightedness, run by Université de Montréal at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Nearsightedness
- What is being tested?
- Experimental: Myopic defocus soft lens design (MDSL) and Active Comparator: Single vision soft lens design (SVSL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jun 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- · Astigmatism ≤ 1.00 D
- Myopia between -0.50 and -4.00D
- Aged between 18 and 35
- Binocular acuity of 6/6 or better
Who cannot join
- · 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
Show all 9Show fewer
- Being pregnant or breast-feeding
- History of refractive surgery
- Addiction to drugs or alcohol
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the detailed description
Objective:
The aim 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 contact lens used in another (ongoing) research project (NCT05191134).
The primary objective of the study is to evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus following one week's wear of a high peripheral add soft contact lens in a population of young myopic adults.
The second objective is to assess changes in choroidal thickness at the macular level after one week's wear of the high peripheral add soft contact lens.
A third objective is to evaluate, through questionnaire, the visual comfort provided by this lens design.
Materials and methods:
25 myopic participants aged between 18 and 35 will be enrolled. Each participant will be randomly fitted with two lenses: a monofocal spherical soft lens (nesofilcon A) for one week and a high-add bifocal soft lens (anti-myopia) for the same duration of time. Participants will be asked to attend three different visits, one week apart.
At visit #1, initial measurements of deep and superficial plexus blood vessel density and choroidal thickness will be taken with an angiographic optical coherence tomograph (OCT-A Triton, Topcon USA).
These measurements will be repeated with other lenses at visit 2 and 3.
The results will be compared. Participants will be asked to evaluate the visual performance of each lens after 1 week of wear through a questionnaire.
Hypothesis: It is expected that one week's wear of the peripheral myopic defocus contact lens will cause an increase in blood vessel density and a thickening of the choroid compared with initial measurements. A decrease in blood vessel density and choroidal thinning is expected after one week's wear of the spherical soft lens (hyperopic defocus), compared with baseline. Both lenses will be well tolerated during daily activities.
- Conditions
- Nearsightedness
- Being tested
- Experimental: Myopic defocus soft lens design (MDSL), Active Comparator: Single vision soft lens design (SVSL
- Keywords
- myopia, retinal vasculature, choroidal thickness
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Myopic defocus soft lens design (MDSL)Device
An optical device designed to provide a myopic defocus to control myopia progression
Active Comparator: Single vision soft lens design (SVSLDevice
An optical device designed to correct refractive error like myopia
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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. Receives: Device: Active Comparator: Single vision soft lens design (SVSL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Measurement done at baseline and after 1 week of contact lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start25 Jun 2024
- Primary completion31 Jan 2025
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for NearsightednessStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor
- Investigators
- Langis Michaud, OD MS, Principal investigator, Universite de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527274
- Sponsor's protocol ID
- 2024-5133
- Status last verified
- Mar 2025
- First submitted
- 8 Jul 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21556938Harb 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.
PubMed 25896460Ostrin 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.
PubMed 37126359Chiang 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.
PubMed 26010292Wang 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.
PubMed 27537606Breher 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.
PubMed 30444900Campbell 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.
PubMed 28186181Swiatczak 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.
PubMed 36171460Wang 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.
PubMed 32758186
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization
- ClinicalTrials.gov ID
- NCT06527274
- Acronym / sponsor ID
- 2024-5133
- Conditions
- Nearsightedness
- Keywords
- myopia, retinal vasculature, choroidal thickness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 30 Jul 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 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.
Detailed description
Objective:
The aim 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 contact lens used in another (ongoing) research project (NCT05191134).
The primary objective of the study is to evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus following one week's wear of a high peripheral add soft contact lens in a population of young myopic adults.
The second objective is to assess changes in choroidal thickness at the macular level after one week's wear of the high peripheral add soft contact lens.
A third objective is to evaluate, through questionnaire, the visual comfort provided by this lens design.
Materials and methods:
25 myopic participants aged between 18 and 35 will be enrolled. Each participant will be randomly fitted with two lenses: a monofocal spherical soft lens (nesofilcon A) for one week and a high-add bifocal soft lens (anti-myopia) for the same duration of time. Participants will be asked to attend three different visits, one week apart.
At visit #1, initial measurements of deep and superficial plexus blood vessel density and choroidal thickness will be taken with an angiographic optical coherence tomograph (OCT-A Triton, Topcon USA).
These measurements will be repeated with other lenses at visit 2 and 3.
The results will be compared. Participants will be asked to evaluate the visual performance of each lens after 1 week of wear through a questionnaire.
Hypothesis: It is expected that one week's wear of the peripheral myopic defocus contact lens will cause an increase in blood vessel density and a thickening of the choroid compared with initial measurements. A decrease in blood vessel density and choroidal thinning is expected after one week's wear of the spherical soft lens (hyperopic defocus), compared with baseline. Both lenses will be well tolerated during daily activities.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Myopic defocus soft lens design (MDSL) | Experimental | Device: Experimental: Myopic defocus soft lens design (MDSL)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.) |
| Single vision soft lens design (SVSL) | Active comparator | Device: Active Comparator: Single vision soft lens design (SVSLThis 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- · Astigmatism ≤ 1.00 D
Key exclusion criteria (9 listed)
- · Recent intake (< 3 months) of medication affecting blood pressure (e.g. hypotensive, anovulant, CNS stimulant, etc.).
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 |
|---|---|---|
| Experimental: Myopic defocus soft lens design (MDSL)An optical device designed to provide a myopic defocus to control myopia progression | Device | Myopic defocus soft lens design (MDSL) |
| Active Comparator: Single vision soft lens design (SVSLAn optical device designed to correct refractive error like myopia | Device | Single vision soft lens design (SVSL) |
Primary outcome
Measurement of Retinal blood vessel density measured by Triton OCT-A
Time frame: Measurement done at baseline and after 1 week of contact lens wear
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Background: PubMed 21556938Agawa 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.
- Background: PubMed 25896460Harb 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.
- Background: PubMed 37126359Ostrin 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.
- Background: PubMed 26010292Chiang 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.
- Background: PubMed 27537606Wang 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.
- Background: PubMed 30444900Breher 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.
- Background: PubMed 28186181Campbell 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.
- Background: PubMed 36171460Swiatczak 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.
- Background: PubMed 32758186Wang 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.
- 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.
Langis Michaud, OD MS principal investigator
Universite de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Myopic defocus soft lens design (MDSL) and Active Comparator: Single vision soft lens design (SVSL in people with Nearsightedness, run by Université de Montréal at 1 site in Canada.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Measurement of Retinal blood vessel density measured by Triton OCT-A (time frame: Measurement done at baseline and after 1 week of contact lens wear). 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 NCT06527274, which also lists 9 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 27 Mar 2025.