AstigmatismVOTENCT03728218
Visual Outcomes for Toric Efficacy Study
A study testing Contact lenses (Orthokeratology) and Contact lenses (Soft Multifocal) in people with Astigmatism and Myopia, run by University of Houston at 1 site in United States.
Trial summary
This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals). Primary aims are to quantify correction of astigmatism, subjective and objective visual performance, aberrometry, peripheral refraction and bacterial bioburden between toric orthokeratology and soft toric multifocal… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Astigmatism, Myopia
- What is being tested?
- Contact lenses (Orthokeratology) and Contact lenses (Soft Multifocal)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2018to 19 Mar 2020
- 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 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 39 years of age (inclusive)
- Able to read and understand the study informed consent
- Plano to -5.00 D (inclusive) vertex corrected sphere power in each eye
- 1.25 to -3.50 D (inclusive) vertex corrected astigmatism in each eye
- Best corrected acuity of 20/25 or better in each eye
- No history of ocular pathology or surgery
Show all 10Show fewer
- No significant binocular vision or accommodation abnormality (i.e. strabismus, amblyopia)
- No gas permeable lens wear for at least 1 month
- No systemic or ocular contraindications for contact lens wear
- Not pregnant/lactating (by self-report)
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Students for whom one of the principal investigators have direct access to/influence on grades would be consented and seen by another investigator for all visits.
- Pregnant/lactating women (by self-report)
Trial locations and contacts
1 site in 1 country.
About this study
This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals). Primary aims are to quantify correction of astigmatism, subjective and objective visual performance, aberrometry, peripheral refraction and bacterial bioburden between toric orthokeratology and soft toric multifocal contact lenses.
- Conditions
- Astigmatism, Myopia
- Being tested
- Contact lenses (Orthokeratology), Contact lenses (Soft Multifocal)
- Medical subject headings
- Astigmatism, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact lenses (Orthokeratology)Device
Contact lenses
Contact lenses (Soft Multifocal)Device
Contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Orthokeratology Contact lenses | Experimental | Not described Receives: Device: Contact lenses (Orthokeratology) |
| Soft Multifocal Contact lenses | Experimental | Not described Receives: Device: Contact lenses (Soft Multifocal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance low contrast visual acuity
Monocular and binocular logMAR visual acuity
Measured: Up to two hours
Secondary outcomes (1)
Residual refractive error measured monocularly by cyclopleged auto-refraction
Cycloplegic auto-refraction to measure residual myopia/hyperopia and astigmatism
Measured: Up to two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start12 Oct 2018
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
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 AstigmatismStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals).
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Richdale, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728218
- Sponsor's protocol ID
- STUDY00001070
- Acronym
- VOTE
- Status last verified
- Jul 2020
- First submitted
- 29 Oct 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Cheung SW, Cho P. Subjective and objective assessments of the effect of orthokeratology--a cross-sectional study. Curr Eye Res. 2004 Feb;28(2):121-7. doi: 10.1076/ceyr.28.2.121.26236.
PubMed 14972717Berntsen DA, Barr CD, Mutti DO, Zadnik K. Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses. Invest Ophthalmol Vis Sci. 2013 Aug 27;54(8):5761-70. doi: 10.1167/iovs.13-11904.
PubMed 23838771Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R, Suzaki A. The effects of entrance pupil centration and coma aberrations on myopic progression following orthokeratology. Clin Exp Optom. 2015 Nov;98(6):534-40. doi: 10.1111/cxo.12297. Epub 2015 Aug 17.
PubMed 26283026Benavente-Perez A, Nour A, Troilo D. Axial eye growth and refractive error development can be modified by exposing the peripheral retina to relative myopic or hyperopic defocus. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6765-73. doi: 10.1167/iovs.14-14524.
PubMed 25190657Kleinstein RN, Jones LA, Hullett S, Kwon S, Lee RJ, Friedman NE, Manny RE, Mutti DO, Yu JA, Zadnik K; Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error Study Group. Refractive error and ethnicity in children. Arch Ophthalmol. 2003 Aug;121(8):1141-7. doi: 10.1001/archopht.121.8.1141.
PubMed 12912692Berntsen DA, Kramer CE. Peripheral defocus with spherical and multifocal soft contact lenses. Optom Vis Sci. 2013 Nov;90(11):1215-24. doi: 10.1097/OPX.0000000000000066.
PubMed 24076542Van Meter WS, Musch DC, Jacobs DS, Kaufman SC, Reinhart WJ, Udell IJ; American Academy of Ophthalmology. Safety of overnight orthokeratology for myopia: a report by the American Academy of Ophthalmology. Ophthalmology. 2008 Dec;115(12):2301-2313.e1. doi: 10.1016/j.ophtha.2008.06.034. Epub 2008 Sep 20.
PubMed 18804868Luo M, Ma S, Liang N. Clinical efficacy of toric orthokeratology in myopic adolescent with moderate to high astigmatism. Eye Sci. 2014 Dec;29(4):209-13, 218.
PubMed 26016072Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6510-7. doi: 10.1167/iovs.13-12527.
PubMed 24003088Zimmerman AB, Nixon AD, Rueff EM. Contact lens associated microbial keratitis: practical considerations for the optometrist. Clin Optom (Auckl). 2016 Jan 29;8:1-12. doi: 10.2147/OPTO.S66424. eCollection 2016.
PubMed 30214344Bullimore MA, Sinnott LT, Jones-Jordan LA. The risk of microbial keratitis with overnight corneal reshaping lenses. Optom Vis Sci. 2013 Sep;90(9):937-44. doi: 10.1097/OPX.0b013e31829cac92.
PubMed 23892491Tomiyama ES, Richdale K. Clinical Outcomes of a Randomized Trial with Contact Lenses for Astigmatic Myopia Management. Optom Vis Sci. 2023 Jan 1;100(1):9-16. doi: 10.1097/OPX.0000000000001969. Epub 2022 Dec 6.
PubMed 36705710Tomiyama ES, Logan AK, Richdale K. Corneal Elevation, Power, and Astigmatism to Assess Toric Orthokeratology Lenses in Moderate-to-High Astigmats. Eye Contact Lens. 2021 Feb 1;47(2):86-90. doi: 10.1097/ICL.0000000000000721.
PubMed 32568927
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes for Toric Efficacy Study
- ClinicalTrials.gov ID
- NCT03728218
- Acronym / sponsor ID
- VOTE / STUDY00001070
- Conditions
- Astigmatism, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 2 Nov 2018 (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.
This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals). Primary aims are to quantify correction of astigmatism, subjective and objective visual performance, aberrometry, peripheral refraction and bacterial bioburden between toric orthokeratology and soft toric multifocal contact lenses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals).
| Arm | Type | Receives |
|---|---|---|
| Orthokeratology Contact lenses | Experimental | Device: Contact lenses (Orthokeratology) |
| Soft Multifocal Contact lenses | Experimental | Device: Contact lenses (Soft Multifocal) |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 18 to 39 years of age (inclusive)
- Able to read and understand the study informed consent
- Plano to -5.00 D (inclusive) vertex corrected sphere power in each eye
- 1.25 to -3.50 D (inclusive) vertex corrected astigmatism in each eye
- Best corrected acuity of 20/25 or better in each eye
Key exclusion criteria (5 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Students for whom one of the principal investigators have direct access to/influence on grades would be consented and seen by another investigator for all visits.
- Pregnant/lactating women (by self-report)
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 |
|---|---|---|
| Contact lenses (Orthokeratology)Contact lenses | Device | Orthokeratology Contact lenses |
| Contact lenses (Soft Multifocal)Contact lenses | Device | Soft Multifocal Contact lenses |
Primary outcome
Distance low contrast visual acuity
Time frame: Up to two hours
Monocular and binocular logMAR visual acuity
1 secondary outcome
Residual refractive error measured monocularly by cyclopleged auto-refraction
Time frame: Up to two hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Background: PubMed 14972717Cheung SW, Cho P. Subjective and objective assessments of the effect of orthokeratology--a cross-sectional study. Curr Eye Res. 2004 Feb;28(2):121-7. doi: 10.1076/ceyr.28.2.121.26236.
- Background: PubMed 23838771Berntsen DA, Barr CD, Mutti DO, Zadnik K. Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses. Invest Ophthalmol Vis Sci. 2013 Aug 27;54(8):5761-70. doi: 10.1167/iovs.13-11904.
- Background: PubMed 26283026Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R, Suzaki A. The effects of entrance pupil centration and coma aberrations on myopic progression following orthokeratology. Clin Exp Optom. 2015 Nov;98(6):534-40. doi: 10.1111/cxo.12297. Epub 2015 Aug 17.
- Background: PubMed 25190657Benavente-Perez A, Nour A, Troilo D. Axial eye growth and refractive error development can be modified by exposing the peripheral retina to relative myopic or hyperopic defocus. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6765-73. doi: 10.1167/iovs.14-14524.
- Background: PubMed 12912692Kleinstein RN, Jones LA, Hullett S, Kwon S, Lee RJ, Friedman NE, Manny RE, Mutti DO, Yu JA, Zadnik K; Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error Study Group. Refractive error and ethnicity in children. Arch Ophthalmol. 2003 Aug;121(8):1141-7. doi: 10.1001/archopht.121.8.1141.
- Background: PubMed 24076542Berntsen DA, Kramer CE. Peripheral defocus with spherical and multifocal soft contact lenses. Optom Vis Sci. 2013 Nov;90(11):1215-24. doi: 10.1097/OPX.0000000000000066.
- Background: PubMed 18804868Van Meter WS, Musch DC, Jacobs DS, Kaufman SC, Reinhart WJ, Udell IJ; American Academy of Ophthalmology. Safety of overnight orthokeratology for myopia: a report by the American Academy of Ophthalmology. Ophthalmology. 2008 Dec;115(12):2301-2313.e1. doi: 10.1016/j.ophtha.2008.06.034. Epub 2008 Sep 20.
- Background: PubMed 26016072Luo M, Ma S, Liang N. Clinical efficacy of toric orthokeratology in myopic adolescent with moderate to high astigmatism. Eye Sci. 2014 Dec;29(4):209-13, 218.
- Background: PubMed 24003088Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6510-7. doi: 10.1167/iovs.13-12527.
- Background: PubMed 30214344Zimmerman AB, Nixon AD, Rueff EM. Contact lens associated microbial keratitis: practical considerations for the optometrist. Clin Optom (Auckl). 2016 Jan 29;8:1-12. doi: 10.2147/OPTO.S66424. eCollection 2016.
- Background: PubMed 23892491Bullimore MA, Sinnott LT, Jones-Jordan LA. The risk of microbial keratitis with overnight corneal reshaping lenses. Optom Vis Sci. 2013 Sep;90(9):937-44. doi: 10.1097/OPX.0b013e31829cac92.
- Derived from this study: PubMed 36705710Tomiyama ES, Richdale K. Clinical Outcomes of a Randomized Trial with Contact Lenses for Astigmatic Myopia Management. Optom Vis Sci. 2023 Jan 1;100(1):9-16. doi: 10.1097/OPX.0000000000001969. Epub 2022 Dec 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contact lenses (Orthokeratology) and Contact lenses (Soft Multifocal) in people with Astigmatism and Myopia, run by University of Houston 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 14 Jul 2020. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Distance low contrast visual acuity (time frame: Up to two hours). 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 NCT03728218, 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 14 Jul 2020.