Myopia, ProgressiveNCT04334369
Contact Lens and Myopia Control in Optometry School Students
A study testing Proclear Single Vision Contact Lenses manufactured by CooperVision and Proclear Multifocal Contact Lenses manufactured by CooperVision in people with Myopia, Progressive, run by Jeff Rabin at 1 site in United States.
Trial summary
The purpose of the study is to determine the effect of Natural View Multifocal lenses, a soft multifocal lens, on retardation of myopia in an optometric student population. Close up work (i.e. reading, computer work, etc.) is thought to play a factor in the progression of myopia in young adults. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- Proclear Single Vision Contact Lenses manufactured by CooperVision and Proclear Multifocal Contact Lenses manufactured by CooperVision
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2018to 3 Jul 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Be first or second year Optometric students at RSO
- Be non-presbyopic
- Have at least -0.50 Diopters or more of myopia in one or both eyes
- Have no systemic health issues
- Have no previous history of Orthokeratology
- Have no gas permeable contact use in the last 6 months
Show all 9Show fewer
- Not be enrolled in any other eye study
- Be able to have a cycloplegic refraction
- New and existing contact lens wearers
Who cannot join
- Progressive retinal or corneal disorder as well as any of the above
Trial locations and contacts
1 site in 1 country.
United States1 site
Bowden Eye Care & Health Center
San Antonio, Texas, 78203
About this study
Official title: Does Specialty Soft Contact Lens Wear Decrease the Onset and Progression of Myopia in Optometry School Interns?
The purpose of the study is to determine the effect of Natural View Multifocal lenses, a soft multifocal lens, on retardation of myopia in an optometric student population. Close up work (i.e. reading, computer work, etc.) is thought to play a factor in the progression of myopia in young adults. The progression should be slowed if not stopped through the use of peripheral defocus lenses (Natural View Multifocal) to change the optics of the eye in order to focus the image on the peripheral retina as opposed to behind it.
Read the detailed description
BACKGROUND AND SIGNIFICANCE Myopia is a common refractive error that has increased among young adults and has become more prevalent in the growing population across the globe (Fan, et al 2004). This has been more common in Eastern Asian countries with prevalence of myopia as high as 96.5% among 19 year old soldiers in South Korea. (Shimuzu, et al 2003) In the United States between the 1990's to the 2000's there was a sudden increase of >15% myopia progression (Vitale et al 2009). There has been a correlation between education and myopia progression in urban areas calling into question the amount of close up work and being indoors as opposed to being outside working as in the rural populations (Resnikoff, et al 2004). Children between the ages of 7 to 11 years that were forced to spend 80 minutes per day outside showed a significantly better outcome in regards to onset as well as progression of myopia. Those that were spending 80 minutes per day outside had an average onset of 8.4% and progression of 0.25 diopters whereas the children that were not forced to spend time outside had onset and progression at a rate of 17.7% and 0.38 diopters respectively. (Wu, et al 2013) Myopia progression has become a cause for concern due to the complications that arise from the elongation of the eye. Some of the complications include retinal detachment, choroidal thinning, glaucoma and myopic macular degeneration. In a study of the causes of visual impairment in an adult Chinese population, it was found that myopic macular degeneration was the leading cause of bilateral visual impairment in adults between the ages of 45 and 59 years old and the second highest major cause of bilateral blindness. (Tang Y, et al 2015) Pathological myopia is one of the leading causes of blindness that can be prevented (Kang et. al. 2017).
Recent studies have promising conclusions that soft multifocal contact lenses are a viable option for slowing myopia progression. Many studies have been conducted on the topic of myopic control with soft multifocal contact lenses in young patients. Very little data exists on myopia control methods used in young adults. It is often thought that myopic progression will progress even through to young adults which could potentially necessitate a need for control. If the use of Dual-Focus soft contact lenses in young adults controls myopia, this could become a viable, cost effective method to increase productivity around the world. This is an important factor to consider as the direct and indirect cost of loss of productivity due to uncorrected refractive error is 202 billion dollars. (WHO bulletin 2004). Reducing the negative side effects of myopia and possible reduced vision loss in this specific population can open doors to future research in other populations.
A common treatment for myopia progression is Orthokeratology, in which patients wear a rigid gas permeable contact lens overnight in the hope of reshaping their corneas. A major concern however, with this treatment is the increased risk of infection that comes with wearing a lens overnight. It is also not approved for use on patients with a refractive error of >6.00D of myopia, and is not effective in older adult patients (Cooper et al 2017). Another pitfall of Orthokeratology is that once treatment is stopped, the refractive error of the patient returns to normal. This treatment regimen is easily restricted due to the high cost to the patient. This in turn calls for a type of treatment that can be used during the day, is cost effective, and can be easily disposed of to decrease the risk of infection. If the daily multifocal soft contact lenses are used correctly, any risk of infection or major drawback is greatly reduced. Another method of treatment involves the use of Atropine, which has proven to be successful in controlling the advancement of myopia. This however has side effects including blurry vision, increased sensitivity to light, possible flushing, tachycardia, bradycardia and other undesirable side effects. As the dose of Atropine rises, the reported side effects also increase. (Huy et. al. 2017).
LOCATION, FACULTY AND EQUIPMENT TO BE USED
- University of Incarnate Word Rosenberg School of Optometry Eye and Vision Care Clinic
- IOL Master 500 by Zeiss
- Topography
- Pentacam
SUBJECTS AND INFORMED CONSENT
Ideal subjects should:
- Be first or second year Optometric students at RSO
- Be non-presbyopic
- Have at least -0.50 Diopters or more of myopia in one or both eyes
- Have no systemic health issues
- Have no previous history of Orthokeratology
- Have no gas permeable contact use in the last 6 months
- Not be enrolled in any other eye study
- Be able to have a cycloplegic refraction
- New and existing contact lens wearers An announcement will be made to the incoming and 2nd year classes in the classroom at the end of one of their lectures. Also a class wide email will be sent out to the 1st and 2nd years giving them the necessary information. A copy of the informers consent will be given for signature. Proper insertion and removal training will be given to new wearers.
DURATION Recruitment will cease within the first 2 months of the study. Data collection and analysis will be ongoing throughout the course of the study. The participants of this study will be monitored at 6 month intervals until their 4t h year of Optometry school.
TESTING Active time during each visit is about 30 minutes, potentially up to 60 minutes including inactive time. Through the use of the G-Power analysis we have decided that ideally 40 patients will be needed. All tasks will be provided by any available investigators or research staff, under necessary supervision.
One year visit : is a comprehensive exam (uncorrected VA, retinoscopy, refraction, cover test at distance and near with prism neutralization, extraocular motility, near point of convergence , amplitude of accommodation, pupil testing in bright and dim lighting, confrontation field, slit lamp exam with dry eye testing - sodium fluorescein staining and tear break up time) pentacam, A scan, cycloplegic refraction (cyclopentolate 1%), dilated fundus exam yearly, OCT.
Uncorrected VA, dry refraction, cyclo refraction, cover tests (Distance and near), amps, slit lamp exam with dry eye eval (TBUT, and sodium fluorescein test) , dilated eye exam, baseline macular OCT
Six month Visit: Comprehensive exam, consider cycloplegic refractions if at least a -0.50D myopic shift or more is suspected. A-Scan, topography, pentacam, visual comfort questionnaire also performed.
Risk Analysis: Bacterial keratitis, corneal neovascularization, dry eyes secondary to contact lens wear, ocular discomfort, potential allergic reactions contact lens solution. All subjects will be given a contact number should they experience any complications during the study.
- Conditions
- Myopia, Progressive
- Being tested
- Proclear Single Vision Contact Lenses manufactured by CooperVision, Proclear Multifocal Contact Lenses manufactured by CooperVision
- Keywords
- Multifocal contact lenses, Myopia progression, Axial length
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proclear Single Vision Contact Lenses manufactured by CooperVisionDevice
FDA approved single vision contact lenses.
Proclear Multifocal Contact Lenses manufactured by CooperVisionDevice
FDA Approved Multifocal Contact Lenses
| Study group | Role | What they receive |
|---|---|---|
| Single Vision Contact Lenses | Sham comparator | Not described Receives: Device: Proclear Single Vision Contact Lenses manufactured by CooperVision |
| Multifocal Contact Lenses | Experimental | Not described Receives: Device: Proclear Multifocal Contact Lenses manufactured by CooperVision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact Lenses and Myopia Progression
Changes in axial length in millimeters
Measured: 3 years
Contact Lenses and Myopia Progression
Progression of Myopia in Diopters
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start12 Dec 2018
- Primary completion3 Jul 2022
- Study completion3 Jul 2022
Why it stopped: LOSS OF FORMER PRINCIPAL INVESTIGATOR
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Myopia, ProgressiveStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeff Rabin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeff Rabin, University of the Incarnate Word
- Investigators
- Mervyn Bloom, OD, Principal investigator, University of the Incarnate Word
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334369
- Sponsor's protocol ID
- RSO myopia control
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2020
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
D. Lee, Y. Pang, R. Patel, M. Patel. A study of myopia progression in young adults Investigate Ophthalmology and Vision Science: An ARVO Journal. 2008;49(13)
Fedtke C, Ehrmann K, Holden BA. A review of peripheral refraction techniques. Optom Vis Sci. 2009 May;86(5):429-46. doi: 10.1097/OPX.0b013e31819fa727.
PubMed 19342977Kang P, McAlinden C, Wildsoet CF. Effects of multifocal soft contact lenses used to slow myopia progression on quality of vision in young adults. Acta Ophthalmol. 2017 Feb;95(1):e43-e53. doi: 10.1111/aos.13173. Epub 2016 Aug 6.
PubMed 27495880Multifocal contact lens effective at treating myopia in kids. American Optometric Association. April 25, 2016. Available from: https://www.aoa.org/news/clinical-eye-care/multifocal-contact-lens-effective-at-treating-myopia-in-kids.
Walline JJ, Greiner KL, McVey ME, Jones-Jordan LA. Multifocal contact lens myopia control. Optom Vis Sci. 2013 Nov;90(11):1207-14. doi: 10.1097/OPX.0000000000000036.
PubMed 24061152Li SM, Ji YZ, Wu SS, Zhan SY, Wang B, Liu LR, Li SY, Wang NL, Wang JJ. Multifocal versus single vision lenses intervention to slow progression of myopia in school-age children: a meta-analysis. Surv Ophthalmol. 2011 Sep-Oct;56(5):451-60. doi: 10.1016/j.survophthal.2011.06.002. Epub 2011 Aug 2.
PubMed 21813146Fan DS, Lam DS, Lam RF, Lau JT, Chong KS, Cheung EY, Lai RY, Chew SJ. Prevalence, incidence, and progression of myopia of school children in Hong Kong. Invest Ophthalmol Vis Sci. 2004 Apr;45(4):1071-5. doi: 10.1167/iovs.03-1151.
PubMed 15037570Shimizu N, Nomura H, Ando F, Niino N, Miyake Y, Shimokata H. Refractive errors and factors associated with myopia in an adult Japanese population. Jpn J Ophthalmol. 2003 Jan-Feb;47(1):6-12. doi: 10.1016/s0021-5155(02)00620-2.
PubMed 12586171Vitale S, Sperduto RD, Ferris FL 3rd. Increased prevalence of myopia in the United States between 1971-1972 and 1999-2004. Arch Ophthalmol. 2009 Dec;127(12):1632-9. doi: 10.1001/archophthalmol.2009.303.
PubMed 20008719Resnikoff S, Pascolini D, Mariotti SP, Pokharel GP. Global magnitude of visual impairment caused by uncorrected refractive errors in 2004. Bull World Health Organ. 2008 Jan;86(1):63-70. doi: 10.2471/blt.07.041210.
PubMed 18235892Wu PC, Tsai CL, Wu HL, Yang YH, Kuo HK. Outdoor activity during class recess reduces myopia onset and progression in school children. Ophthalmology. 2013 May;120(5):1080-5. doi: 10.1016/j.ophtha.2012.11.009. Epub 2013 Feb 22.
PubMed 23462271Si JK, Tang K, Bi HS, Guo DD, Guo JG, Wang XR. Orthokeratology for myopia control: a meta-analysis. Optom Vis Sci. 2015 Mar;92(3):252-7. doi: 10.1097/OPX.0000000000000505.
PubMed 25599338Cooper J, O'Connor B, Watanabe R, Fuerst R, Berger S, Eisenberg N, Dillehay SM. Case Series Analysis of Myopic Progression Control With a Unique Extended Depth of Focus Multifocal Contact Lens. Eye Contact Lens. 2018 Sep;44(5):e16-e24. doi: 10.1097/ICL.0000000000000440.
PubMed 29053555
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Specialty Soft Contact Lens Wear Decrease the Onset and Progression of Myopia in Optometry School Interns?
- ClinicalTrials.gov ID
- NCT04334369
- Acronym / sponsor ID
- RSO myopia control
- Conditions
- Myopia, Progressive
- Keywords
- Multifocal contact lenses, Myopia progression, Axial length
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: LOSS OF FORMER PRINCIPAL INVESTIGATOR
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jeff RabinUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 3 Jul 2022 (actual)
- Study completion
- 3 Jul 2022 (actual)
- First posted
- 6 Apr 2020 (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 the study is to determine the effect of Natural View Multifocal lenses, a soft multifocal lens, on retardation of myopia in an optometric student population. Close up work (i.e. reading, computer work, etc.) is thought to play a factor in the progression of myopia in young adults. The progression should be slowed if not stopped through the use of peripheral defocus lenses (Natural View Multifocal) to change the optics of the eye in order to focus the image on the peripheral retina as opposed to behind it.
Detailed description
BACKGROUND AND SIGNIFICANCE Myopia is a common refractive error that has increased among young adults and has become more prevalent in the growing population across the globe (Fan, et al 2004). This has been more common in Eastern Asian countries with prevalence of myopia as high as 96.5% among 19 year old soldiers in South Korea. (Shimuzu, et al 2003) In the United States between the 1990's to the 2000's there was a sudden increase of >15% myopia progression (Vitale et al 2009). There has been a correlation between education and myopia progression in urban areas calling into question the amount of close up work and being indoors as opposed to being outside working as in the rural populations (Resnikoff, et al 2004). Children between the ages of 7 to 11 years that were forced to spend 80 minutes per day outside showed a significantly better outcome in regards to onset as well as progression of myopia. Those that were spending 80 minutes per day outside had an average onset of 8.4% and progression of 0.25 diopters whereas the children that were not forced to spend time outside had onset and progression at a rate of 17.7% and 0.38 diopters respectively. (Wu, et al 2013) Myopia progression has become a cause for concern due to the complications that arise from the elongation of the eye. Some of the complications include retinal detachment, choroidal thinning, glaucoma and myopic macular degeneration. In a study of the causes of visual impairment in an adult Chinese population, it was found that myopic macular degeneration was the leading cause of bilateral visual impairment in adults between the ages of 45 and 59 years old and the second highest major cause of bilateral blindness. (Tang Y, et al 2015) Pathological myopia is one of the leading causes of blindness that can be prevented (Kang et. al. 2017).
Recent studies have promising conclusions that soft multifocal contact lenses are a viable option for slowing myopia progression. Many studies have been conducted on the topic of myopic control with soft multifocal contact lenses in young patients. Very little data exists on myopia control methods used in young adults. It is often thought that myopic progression will progress even through to young adults which could potentially necessitate a need for control. If the use of Dual-Focus soft contact lenses in young adults controls myopia, this could become a viable, cost effective method to increase productivity around the world. This is an important factor to consider as the direct and indirect cost of loss of productivity due to uncorrected refractive error is 202 billion dollars. (WHO bulletin 2004). Reducing the negative side effects of myopia and possible reduced vision loss in this specific population can open doors to future research in other populations.
A common treatment for myopia progression is Orthokeratology, in which patients wear a rigid gas permeable contact lens overnight in the hope of reshaping their corneas. A major concern however, with this treatment is the increased risk of infection that comes with wearing a lens overnight. It is also not approved for use on patients with a refractive error of >6.00D of myopia, and is not effective in older adult patients (Cooper et al 2017). Another pitfall of Orthokeratology is that once treatment is stopped, the refractive error of the patient returns to normal. This treatment regimen is easily restricted due to the high cost to the patient. This in turn calls for a type of treatment that can be used during the day, is cost effective, and can be easily disposed of to decrease the risk of infection. If the daily multifocal soft contact lenses are used correctly, any risk of infection or major drawback is greatly reduced. Another method of treatment involves the use of Atropine, which has proven to be successful in controlling the advancement of myopia. This however has side effects including blurry vision, increased sensitivity to light, possible flushing, tachycardia, bradycardia and other undesirable side effects. As the dose of Atropine rises, the reported side effects also increase. (Huy et. al. 2017).
LOCATION, FACULTY AND EQUIPMENT TO BE USED
- University of Incarnate Word Rosenberg School of Optometry Eye and Vision Care Clinic
- IOL Master 500 by Zeiss
- Topography
- Pentacam
SUBJECTS AND INFORMED CONSENT
Ideal subjects should:
- Be first or second year Optometric students at RSO
- Be non-presbyopic
- Have at least -0.50 Diopters or more of myopia in one or both eyes
- Have no systemic health issues
- Have no previous history of Orthokeratology
- Have no gas permeable contact use in the last 6 months
- Not be enrolled in any other eye study
- Be able to have a cycloplegic refraction
- New and existing contact lens wearers An announcement will be made to the incoming and 2nd year classes in the classroom at the end of one of their lectures. Also a class wide email will be sent out to the 1st and 2nd years giving them the necessary information. A copy of the informers consent will be given for signature. Proper insertion and removal training will be given to new wearers.
DURATION Recruitment will cease within the first 2 months of the study. Data collection and analysis will be ongoing throughout the course of the study. The participants of this study will be monitored at 6 month intervals until their 4t h year of Optometry school.
TESTING Active time during each visit is about 30 minutes, potentially up to 60 minutes including inactive time. Through the use of the G-Power analysis we have decided that ideally 40 patients will be needed. All tasks will be provided by any available investigators or research staff, under necessary supervision.
One year visit : is a comprehensive exam (uncorrected VA, retinoscopy, refraction, cover test at distance and near with prism neutralization, extraocular motility, near point of convergence , amplitude of accommodation, pupil testing in bright and dim lighting, confrontation field, slit lamp exam with dry eye testing - sodium fluorescein staining and tear break up time) pentacam, A scan, cycloplegic refraction (cyclopentolate 1%), dilated fundus exam yearly, OCT.
Uncorrected VA, dry refraction, cyclo refraction, cover tests (Distance and near), amps, slit lamp exam with dry eye eval (TBUT, and sodium fluorescein test) , dilated eye exam, baseline macular OCT
Six month Visit: Comprehensive exam, consider cycloplegic refractions if at least a -0.50D myopic shift or more is suspected. A-Scan, topography, pentacam, visual comfort questionnaire also performed.
Risk Analysis: Bacterial keratitis, corneal neovascularization, dry eyes secondary to contact lens wear, ocular discomfort, potential allergic reactions contact lens solution. All subjects will be given a contact number should they experience any complications during the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Vision Contact Lenses | Sham comparator | Device: Proclear Single Vision Contact Lenses manufactured by CooperVision |
| Multifocal Contact Lenses | Experimental | Device: Proclear Multifocal Contact Lenses manufactured by CooperVision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Be first or second year Optometric students at RSO
- Be non-presbyopic
- Have at least -0.50 Diopters or more of myopia in one or both eyes
- Have no systemic health issues
- Have no previous history of Orthokeratology
Key exclusion criteria (1 listed)
- Progressive retinal or corneal disorder as well as any of the above
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 |
|---|---|---|
| Proclear Single Vision Contact Lenses manufactured by CooperVisionFDA approved single vision contact lenses. | Device | Single Vision Contact Lenses |
| Proclear Multifocal Contact Lenses manufactured by CooperVisionFDA Approved Multifocal Contact Lenses | Device | Multifocal Contact Lenses |
Primary outcome
Contact Lenses and Myopia Progression
Time frame: 3 years
Changes in axial length in millimeters
Contact Lenses and Myopia Progression
Time frame: 3years
Progression of Myopia in Diopters
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- BackgroundD. Lee, Y. Pang, R. Patel, M. Patel. A study of myopia progression in young adults Investigate Ophthalmology and Vision Science: An ARVO Journal. 2008;49(13)
- Background: PubMed 19342977Fedtke C, Ehrmann K, Holden BA. A review of peripheral refraction techniques. Optom Vis Sci. 2009 May;86(5):429-46. doi: 10.1097/OPX.0b013e31819fa727.
- Background: PubMed 27495880Kang P, McAlinden C, Wildsoet CF. Effects of multifocal soft contact lenses used to slow myopia progression on quality of vision in young adults. Acta Ophthalmol. 2017 Feb;95(1):e43-e53. doi: 10.1111/aos.13173. Epub 2016 Aug 6.
- BackgroundMultifocal contact lens effective at treating myopia in kids. American Optometric Association. April 25, 2016. Available from: https://www.aoa.org/news/clinical-eye-care/multifocal-contact-lens-effective-at-treating-myopia-in-kids.
- Background: PubMed 24061152Walline JJ, Greiner KL, McVey ME, Jones-Jordan LA. Multifocal contact lens myopia control. Optom Vis Sci. 2013 Nov;90(11):1207-14. doi: 10.1097/OPX.0000000000000036.
- Background: PubMed 21813146Li SM, Ji YZ, Wu SS, Zhan SY, Wang B, Liu LR, Li SY, Wang NL, Wang JJ. Multifocal versus single vision lenses intervention to slow progression of myopia in school-age children: a meta-analysis. Surv Ophthalmol. 2011 Sep-Oct;56(5):451-60. doi: 10.1016/j.survophthal.2011.06.002. Epub 2011 Aug 2.
- Background: PubMed 15037570Fan DS, Lam DS, Lam RF, Lau JT, Chong KS, Cheung EY, Lai RY, Chew SJ. Prevalence, incidence, and progression of myopia of school children in Hong Kong. Invest Ophthalmol Vis Sci. 2004 Apr;45(4):1071-5. doi: 10.1167/iovs.03-1151.
- Background: PubMed 12586171Shimizu N, Nomura H, Ando F, Niino N, Miyake Y, Shimokata H. Refractive errors and factors associated with myopia in an adult Japanese population. Jpn J Ophthalmol. 2003 Jan-Feb;47(1):6-12. doi: 10.1016/s0021-5155(02)00620-2.
- Background: PubMed 20008719Vitale S, Sperduto RD, Ferris FL 3rd. Increased prevalence of myopia in the United States between 1971-1972 and 1999-2004. Arch Ophthalmol. 2009 Dec;127(12):1632-9. doi: 10.1001/archophthalmol.2009.303.
- Background: PubMed 18235892Resnikoff S, Pascolini D, Mariotti SP, Pokharel GP. Global magnitude of visual impairment caused by uncorrected refractive errors in 2004. Bull World Health Organ. 2008 Jan;86(1):63-70. doi: 10.2471/blt.07.041210.
- Background: PubMed 23462271Wu PC, Tsai CL, Wu HL, Yang YH, Kuo HK. Outdoor activity during class recess reduces myopia onset and progression in school children. Ophthalmology. 2013 May;120(5):1080-5. doi: 10.1016/j.ophtha.2012.11.009. Epub 2013 Feb 22.
- Background: PubMed 25599338Si JK, Tang K, Bi HS, Guo DD, Guo JG, Wang XR. Orthokeratology for myopia control: a meta-analysis. Optom Vis Sci. 2015 Mar;92(3):252-7. doi: 10.1097/OPX.0000000000000505.
- 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.
Mervyn Bloom, OD principal investigator
University of the Incarnate Word
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proclear Single Vision Contact Lenses manufactured by CooperVision and Proclear Multifocal Contact Lenses manufactured by CooperVision in people with Myopia, Progressive, run by Jeff Rabin at 1 site in United States.
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 9 inclusion and 1 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: withdrawn, as of the sponsor's last update on 7 Jul 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Contact Lenses and Myopia Progression (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT04334369, which also lists 13 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 7 Jul 2022.