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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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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:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.) |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Myopic defocus soft lens design (MDSL) | Device | An optical device designed to provide a myopic defocus to control myopia progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the choroidal thickness at the macular area | A 3D scan (OCT- Heidelberg) 6.0mm x 6.0mm will be performed for analysis of choroidal thickness in the different ETDRS quadrants. Choroidal thickness data per quadrant (1-5) will be available in the 6mm CSI analysis (BM-CSI) | Measurement done at baseline and after 1 week of contact lens wear |
Inclusion Criteria:
· Astigmatism ≤ 1.00 D
Exclusion Criteria:
· Recent intake (< 3 months) of medication affecting blood pressure (e.g. hypotensive, anovulant, CNS stimulant, etc.).
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| Name | Affiliation | Role |
|---|---|---|
| Langis Michaud, OD MS | Universite de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universite de Montreal | Montreal | Quebec | H3T1P1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21556938 | Background | 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. | |
| 25896460 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 9, 2024 | Jul 23, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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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
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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.
| Active Comparator: Single vision soft lens design (SVSL | Device | An optical device designed to correct refractive error like myopia |
|
| 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. |
| 37126359 | 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. |
| 26010292 | 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. |
| 27537606 | 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. |
| 30444900 | 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. |
| 28186181 | 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. |
| 36171460 | 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. |
| 32758186 | 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. |
Protocol and other documentation available upon request to the principal investigator email |