MyopiaPhase 4NCT03544827
The Effects of Low Dose Atropine on Choroidal Thickness
A Phase 4 study testing Atropine in people with Myopia, run by State University of New York College of Optometry at 1 site in United States.
Trial summary
Atropine eye drops are considered to be an effective form of myopia control in human eyes. However, the mechanism by which it exerts it effects are not fully understood. Thickening of the choroid subsequent to atropine administration may play an important role in the mechanisms by which atropine induces myopia… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2018to 8 Feb 2019
- Phase
- Phase 4
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 - 35 years
- Good general and ocular health
- Soft contact lens wearers to cease lens wear for at least 24 hours
- No previous rigid gas permeable lens wear
- Not taking monoamine oxidase inhibitors (MAOIs) and are not pregnant
Who cannot join
- History of ocular surgery, including refractive surgery
- Use of ocular medications
- Amblyopia
- Conditions where topical atropine is contraindicated
- Any eye or systemic disease that affect vision or refractive error
Trial locations and contacts
1 site in 1 country.
About this study
Atropine eye drops are considered to be an effective form of myopia control in human eyes. However, the mechanism by which it exerts it effects are not fully understood. Thickening of the choroid subsequent to atropine administration may play an important role in the mechanisms by which atropine induces myopia control. Literature also notes that choroidal thickness undergoes diurnal variations, which is a variable that will be controlled in this study in order to examine atropine's effects on different baseline choroidal thicknesses.
The purpose of the proposed study is to characterize better the influence of atropine on choroid thickness. The study aims are to:
Read more
- Determine the effect of low dose concentration of topical atropine (0.1% and 0.01%) on choroid thickness
- Determine the effect of topical atropine on choroid thickness in relationship to baseline thickness throughout the day and after one week of daily instillation
Hypothesis: Atropine's effect on choroidal thickness will be dependent on the subject's baseline thickness measurements, at a designated time of the day when the choroid is at its thinnest.
Read the detailed description
Atropine eye drops are an effective form of myopia control in children with progressive myopia1, but the mechanism in which this occurs is still not fully understood.
The choroid has been established to play a significant role in the modulation of ocular growth in the chick eye;2 eyes with thicker choroids grow slower than eyes with thinner choroids.3 Choroidal compensation has also been discovered in other animal species including tree shrews,4 marmosets,5 rhesus macaques,6 guinea pigs,7, 8 and even in humans.9, 10 A study in humans demonstrated how the thickening of the choroid subsequent to atropine use may contribute to the mechanisms by which atropine induces myopia control.11 These results are supported by another study where children with less choroidal thickening over time exhibited faster axial growth.12 Furthermore, diurnal variation in choroidal thickness has been documented13, 14 and individuals with thinner choroids exhibited less variation in thickness across the day. 13
Currently, atropine is prescribed by eye care providers on a daily basis and administered at night for convenience. However, choroidal thickness undergoes diurnal variations13, and the efficacy of atropine on myopia control in relationship to the patient's baseline choroidal thickness is unknown.
A preliminary study shows that atropine 1% has an effect on reducing choroidal thinning throughout the day, but how this translates to low concentration atropine as is commonly prescribed in myopia control treatment is unknown. Specifically, preliminary results reveal that the maximal pharmaceutical effects on choroidal thickening occurred one hour after atropine 1% instillation in the morning, but its relative efficacy during specific time points and duration of the day is still unclear. Also, baseline diurnal measurements demonstrate that the choroid thins in the morning, is thinnest at noon, and gradually thickens in the evening and overnight. The effects of atropine on the choroid from noon to the afternoon were not explicitly measured in our previous study, and therefore, are measurements of interest. While it is critical to understand the effects of low dose atropine on choroidal thickness throughout the evening as commonly prescribed clinically, it is important to also understand its effects when the choroid is shown to thin during the day. Additionally, the study measured changes in choroidal thickness after one instillation of atropine, but did not explore the effects of daily instillation on choroidal thickness and whether there is further minimization of choroidal thinning.
Thus, the objective of this study is to provide data to characterize the influence of low dose atropine on choroid thickness. The study aims are:
- To determine the effect of low dose topical atropine (0.1% and 0.01%) on choroid thickness
- To determine the effect of topical atropine on choroid thickness in relationship to baseline thickness throughout the day and after one week of daily instillation.
It is hypothesized that atropine's effect on choroidal thickness will be dependent on the subject's baseline thickness measurements, at a designated time of the day when the choroid is at its thinnest.
Potential risks of this study are related to the use of atropine eye drops. Atropine 0.1% and 0.01% eye drops may cause dilation of the pupil (mydriasis) and paralysis of accommodation (cycloplegia).15 There are also rare ocular and systemic adverse effects associated with the use of atropine eye drops as described in section C3 below.15 However, using the minimum dosage in combination with low concentrations of the drug will minimize these adverse effects associated with atropine.16 Participants will be asked if they have experienced any reactions to eye drops in the past. The puncta can be occluded as a preventative measure against systemic absorption. Risks can be further minimized by preparing for adverse systemic side effects and by immediate recognition of the signs and appropriate monitoring. The participant will also be educated to report any unforeseen side effects from instillation of the atropine according to the instructions detailed in consent form. All participants will be trained to promptly report any side effects to the investigators.
Medline and Pubmed databases were used for literature review.
- Conditions
- Myopia
- Being tested
- Atropine
- Keywords
- Atropine
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
Also called Atropine 0.01%, Atropine 0.1%
Atropine 0.01% then atropine 0.1%
AtropineDrug
Also called Atropine 0.1%, Atropine 0.01%
Atropine 0.1% then atropine 0.01%
| Study group | Role | What they receive |
|---|---|---|
| Atropine 0.01% then atropine 0.1% | Experimental | Participants will be on topical atropine 0.01% ophthalmic solution QD OU for 1 week (7 days) and then topical atropine 0.1% ophthalmic solution QD OU for 1 week (7 days) with a washout period of 4 weeks in between each intervention Receives: Drug: Atropine |
| Atropine 0.1% then atropine 0.01% | Experimental | Participants will be on topical atropine 0.1% ophthalmic solution QD OU for 1 week (7 days) and then topical atropine 0.01% ophthalmic solution QD OU for 1 week (7 days) with a washout period of 4 weeks in between each intervention Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness
Measure choroidal thickness changes at baseline and compare to choroidal thickness after intervention of atropine 0.01% and atropine 0.1%
Measured: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Secondary outcomes (8)
Visual acuity
Measure distance and near visual acuity at baseline and re-measure after intervention of atropine 0.01% and atropine 0.1% for any changes
Measured: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Axial length
Measure axial length at baseline and compare to changes after intervention of atropine 0.01% and atropine 0.1%
Measured: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Lens thickness
Measure lens thickness at baseline and compare to changes after intervention of atropine 0.01% and atropine 0.1%
Measured: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Anterior chamber depth
Measure anterior chamber depth at baseline and compare to changes after intervention of atropine 0.01% and atropine 0.1%
Measured: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Quality of Vision (QoV) Questionnaire
The questionnaire is a Rasch-tested, linear-scaled, 30-item instrument on three scales providing a QoV score in terms of symptom frequency, severity, and bothersome. There are four options of increasing severity of symptoms from none, mild, moderate, and to severe for each item. The use of Rasch analysis turns the original questionnaire responses (raw ordinal data) into continuous interval data, providing a linear measurement; it is on a linear interval scale.
Measured: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Tear break up time (TBUT)
Sodium fluorescein dye is added to the eye and the tear film is observed under the slit lamp while the patient avoids blinking until tiny dry spots develop; compare any differences between baseline and after one week of atropine use
Measured: Baseline and 1 week from baseline measurement
Schirmer strip test
Measure amount of tear production; compare value at baseline to values after 1 week of atropine use to determine if tear production is affected with atropine use
Measured: Baseline and 1 week from baseline measurement
Ocular Surface Disease Index (OSDI)
This is a 12-item questionnaire with 5 options from 0 to 5 (with 0 indicating none of the time, and increases to 5 indicating all of the time). The sum of the scores across the 12 items are totaled, and inputted into a formula to generate a sliding scale of the disease condition. The scale ranges from 0 to 100, with higher scores representing greater disability of the disease condition. This questionnaire will be completed at baseline and after 1 week of atropine use to compare for any differences.
Measured: Baseline and 1 week from baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start21 May 2018
- Primary completion8 Feb 2019
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franklin Bui, State University of New York College of Optometry
- Investigators
- Alexandra Benavente-Perez, PhD, Principal investigator, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544827
- Sponsor's protocol ID
- 1168531-2
- Status last verified
- Feb 2019
- First submitted
- 8 May 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chia A, Lu QS, Tan D. Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops. Ophthalmology. 2016 Feb;123(2):391-399. doi: 10.1016/j.ophtha.2015.07.004. Epub 2015 Aug 11.
PubMed 26271839Wallman J, Winawer J. Homeostasis of eye growth and the question of myopia. Neuron. 2004 Aug 19;43(4):447-68. doi: 10.1016/j.neuron.2004.08.008.
PubMed 15312645Nickla DL, Totonelly K. Choroidal thickness predicts ocular growth in normal chicks but not in eyes with experimentally altered growth. Clin Exp Optom. 2015 Nov;98(6):564-70. doi: 10.1111/cxo.12317.
PubMed 26769180Siegwart JT Jr, Norton TT. The susceptible period for deprivation-induced myopia in tree shrew. Vision Res. 1998 Nov;38(22):3505-15. doi: 10.1016/s0042-6989(98)00053-4.
PubMed 9893785Troilo D, Nickla DL, Wildsoet CF. Choroidal thickness changes during altered eye growth and refractive state in a primate. Invest Ophthalmol Vis Sci. 2000 May;41(6):1249-58.
PubMed 10798638Hung LF, Wallman J, Smith EL 3rd. Vision-dependent changes in the choroidal thickness of macaque monkeys. Invest Ophthalmol Vis Sci. 2000 May;41(6):1259-69.
PubMed 10798639Howlett MH, McFadden SA. Form-deprivation myopia in the guinea pig (Cavia porcellus). Vision Res. 2006 Jan;46(1-2):267-83. doi: 10.1016/j.visres.2005.06.036. Epub 2005 Aug 31.
PubMed 16139323Howlett MH, McFadden SA. Spectacle lens compensation in the pigmented guinea pig. Vision Res. 2009 Jan;49(2):219-27. doi: 10.1016/j.visres.2008.10.008. Epub 2008 Dec 4.
PubMed 18992765Woodman EC, Read SA, Collins MJ. Axial length and choroidal thickness changes accompanying prolonged accommodation in myopes and emmetropes. Vision Res. 2012 Nov 1;72:34-41. doi: 10.1016/j.visres.2012.09.009. Epub 2012 Sep 24.
PubMed 23017772Chakraborty R, Read SA, Collins MJ. Monocular myopic defocus and daily changes in axial length and choroidal thickness of human eyes. Exp Eye Res. 2012 Oct;103:47-54. doi: 10.1016/j.exer.2012.08.002. Epub 2012 Aug 16.
PubMed 22971342Zhang Z, Zhou Y, Xie Z, Chen T, Gu Y, Lu S, Wu Z. The effect of topical atropine on the choroidal thickness of healthy children. Sci Rep. 2016 Oct 7;6:34936. doi: 10.1038/srep34936.
PubMed 27713535Read SA, Alonso-Caneiro D, Vincent SJ, Collins MJ. Longitudinal changes in choroidal thickness and eye growth in childhood. Invest Ophthalmol Vis Sci. 2015 May;56(5):3103-12. doi: 10.1167/iovs.15-16446.
PubMed 26024094Tan CS, Ouyang Y, Ruiz H, Sadda SR. Diurnal variation of choroidal thickness in normal, healthy subjects measured by spectral domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Jan 25;53(1):261-6. doi: 10.1167/iovs.11-8782.
PubMed 22167095Chakraborty R, Read SA, Collins MJ. Diurnal variations in axial length, choroidal thickness, intraocular pressure, and ocular biometrics. Invest Ophthalmol Vis Sci. 2011 Jul 11;52(8):5121-9. doi: 10.1167/iovs.11-7364.
PubMed 21571673North RV, Kelly ME. A review of the uses and adverse effects of topical administration of atropine. Ophthalmic Physiol Opt. 1987;7(2):109-14. doi: 10.1111/j.1475-1313.1987.tb01004.x.
PubMed 2958765
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low Dose Atropine on Choroidal Thickness
- ClinicalTrials.gov ID
- NCT03544827
- Acronym / sponsor ID
- 1168531-2
- Conditions
- Myopia
- Keywords
- Atropine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- State University of New York College of OptometryUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 4 Jun 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.
Atropine eye drops are considered to be an effective form of myopia control in human eyes. However, the mechanism by which it exerts it effects are not fully understood. Thickening of the choroid subsequent to atropine administration may play an important role in the mechanisms by which atropine induces myopia control. Literature also notes that choroidal thickness undergoes diurnal variations, which is a variable that will be controlled in this study in order to examine atropine's effects on different baseline choroidal thicknesses.
The purpose of the proposed study is to characterize better the influence of atropine on choroid thickness. The study aims are to:
- Determine the effect of low dose concentration of topical atropine (0.1% and 0.01%) on choroid thickness
- Determine the effect of topical atropine on choroid thickness in relationship to baseline thickness throughout the day and after one week of daily instillation
Hypothesis: Atropine's effect on choroidal thickness will be dependent on the subject's baseline thickness measurements, at a designated time of the day when the choroid is at its thinnest.
Detailed description
Atropine eye drops are an effective form of myopia control in children with progressive myopia1, but the mechanism in which this occurs is still not fully understood.
The choroid has been established to play a significant role in the modulation of ocular growth in the chick eye;2 eyes with thicker choroids grow slower than eyes with thinner choroids.3 Choroidal compensation has also been discovered in other animal species including tree shrews,4 marmosets,5 rhesus macaques,6 guinea pigs,7, 8 and even in humans.9, 10 A study in humans demonstrated how the thickening of the choroid subsequent to atropine use may contribute to the mechanisms by which atropine induces myopia control.11 These results are supported by another study where children with less choroidal thickening over time exhibited faster axial growth.12 Furthermore, diurnal variation in choroidal thickness has been documented13, 14 and individuals with thinner choroids exhibited less variation in thickness across the day. 13
Currently, atropine is prescribed by eye care providers on a daily basis and administered at night for convenience. However, choroidal thickness undergoes diurnal variations13, and the efficacy of atropine on myopia control in relationship to the patient's baseline choroidal thickness is unknown.
A preliminary study shows that atropine 1% has an effect on reducing choroidal thinning throughout the day, but how this translates to low concentration atropine as is commonly prescribed in myopia control treatment is unknown. Specifically, preliminary results reveal that the maximal pharmaceutical effects on choroidal thickening occurred one hour after atropine 1% instillation in the morning, but its relative efficacy during specific time points and duration of the day is still unclear. Also, baseline diurnal measurements demonstrate that the choroid thins in the morning, is thinnest at noon, and gradually thickens in the evening and overnight. The effects of atropine on the choroid from noon to the afternoon were not explicitly measured in our previous study, and therefore, are measurements of interest. While it is critical to understand the effects of low dose atropine on choroidal thickness throughout the evening as commonly prescribed clinically, it is important to also understand its effects when the choroid is shown to thin during the day. Additionally, the study measured changes in choroidal thickness after one instillation of atropine, but did not explore the effects of daily instillation on choroidal thickness and whether there is further minimization of choroidal thinning.
Thus, the objective of this study is to provide data to characterize the influence of low dose atropine on choroid thickness. The study aims are:
- To determine the effect of low dose topical atropine (0.1% and 0.01%) on choroid thickness
- To determine the effect of topical atropine on choroid thickness in relationship to baseline thickness throughout the day and after one week of daily instillation.
It is hypothesized that atropine's effect on choroidal thickness will be dependent on the subject's baseline thickness measurements, at a designated time of the day when the choroid is at its thinnest.
Potential risks of this study are related to the use of atropine eye drops. Atropine 0.1% and 0.01% eye drops may cause dilation of the pupil (mydriasis) and paralysis of accommodation (cycloplegia).15 There are also rare ocular and systemic adverse effects associated with the use of atropine eye drops as described in section C3 below.15 However, using the minimum dosage in combination with low concentrations of the drug will minimize these adverse effects associated with atropine.16 Participants will be asked if they have experienced any reactions to eye drops in the past. The puncta can be occluded as a preventative measure against systemic absorption. Risks can be further minimized by preparing for adverse systemic side effects and by immediate recognition of the signs and appropriate monitoring. The participant will also be educated to report any unforeseen side effects from instillation of the atropine according to the instructions detailed in consent form. All participants will be trained to promptly report any side effects to the investigators.
Medline and Pubmed databases were used for literature review.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine 0.01% then atropine 0.1% | Experimental | Drug: AtropineParticipants will be on topical atropine 0.01% ophthalmic solution QD OU for 1 week (7 days) and then topical atropine 0.1% ophthalmic solution QD OU for 1 week (7 days) with a washout period of 4 weeks in between each intervention |
| Atropine 0.1% then atropine 0.01% | Experimental | Drug: AtropineParticipants will be on topical atropine 0.1% ophthalmic solution QD OU for 1 week (7 days) and then topical atropine 0.01% ophthalmic solution QD OU for 1 week (7 days) with a washout period of 4 weeks in between each intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 18 - 35 years
- Good general and ocular health
- Soft contact lens wearers to cease lens wear for at least 24 hours
- No previous rigid gas permeable lens wear
- Not taking monoamine oxidase inhibitors (MAOIs) and are not pregnant
Key exclusion criteria (5 listed)
- History of ocular surgery, including refractive surgery
- Use of ocular medications
- Amblyopia
- Conditions where topical atropine is contraindicated
- Any eye or systemic disease that affect vision or refractive error
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 |
|---|---|---|
| AtropineAlso: Atropine 0.01%, Atropine 0.1%Atropine 0.01% then atropine 0.1% | Drug | Atropine 0.01% then atropine 0.1%, Atropine 0.1% then atropine 0.01% |
| AtropineAlso: Atropine 0.1%, Atropine 0.01%Atropine 0.1% then atropine 0.01% | Drug | Atropine 0.01% then atropine 0.1%, Atropine 0.1% then atropine 0.01% |
Primary outcome
Choroidal thickness
Time frame: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Measure choroidal thickness changes at baseline and compare to choroidal thickness after intervention of atropine 0.01% and atropine 0.1%
8 secondary outcomes
Visual acuity
Time frame: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Axial length
Time frame: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Lens thickness
Time frame: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Anterior chamber depth
Time frame: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Quality of Vision (QoV) Questionnaire
Time frame: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Tear break up time (TBUT)
Time frame: Baseline and 1 week from baseline measurement
Schirmer strip test
Time frame: Baseline and 1 week from baseline measurement
Ocular Surface Disease Index (OSDI)
Time frame: Baseline and 1 week from baseline measurement
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 15 Feb 2019.
- Background: PubMed 26271839Chia A, Lu QS, Tan D. Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops. Ophthalmology. 2016 Feb;123(2):391-399. doi: 10.1016/j.ophtha.2015.07.004. Epub 2015 Aug 11.
- Background: PubMed 15312645Wallman J, Winawer J. Homeostasis of eye growth and the question of myopia. Neuron. 2004 Aug 19;43(4):447-68. doi: 10.1016/j.neuron.2004.08.008.
- Background: PubMed 26769180Nickla DL, Totonelly K. Choroidal thickness predicts ocular growth in normal chicks but not in eyes with experimentally altered growth. Clin Exp Optom. 2015 Nov;98(6):564-70. doi: 10.1111/cxo.12317.
- Background: PubMed 9893785Siegwart JT Jr, Norton TT. The susceptible period for deprivation-induced myopia in tree shrew. Vision Res. 1998 Nov;38(22):3505-15. doi: 10.1016/s0042-6989(98)00053-4.
- Background: PubMed 10798638Troilo D, Nickla DL, Wildsoet CF. Choroidal thickness changes during altered eye growth and refractive state in a primate. Invest Ophthalmol Vis Sci. 2000 May;41(6):1249-58.
- Background: PubMed 10798639Hung LF, Wallman J, Smith EL 3rd. Vision-dependent changes in the choroidal thickness of macaque monkeys. Invest Ophthalmol Vis Sci. 2000 May;41(6):1259-69.
- Background: PubMed 16139323Howlett MH, McFadden SA. Form-deprivation myopia in the guinea pig (Cavia porcellus). Vision Res. 2006 Jan;46(1-2):267-83. doi: 10.1016/j.visres.2005.06.036. Epub 2005 Aug 31.
- Background: PubMed 18992765Howlett MH, McFadden SA. Spectacle lens compensation in the pigmented guinea pig. Vision Res. 2009 Jan;49(2):219-27. doi: 10.1016/j.visres.2008.10.008. Epub 2008 Dec 4.
- Background: PubMed 23017772Woodman EC, Read SA, Collins MJ. Axial length and choroidal thickness changes accompanying prolonged accommodation in myopes and emmetropes. Vision Res. 2012 Nov 1;72:34-41. doi: 10.1016/j.visres.2012.09.009. Epub 2012 Sep 24.
- Background: PubMed 22971342Chakraborty R, Read SA, Collins MJ. Monocular myopic defocus and daily changes in axial length and choroidal thickness of human eyes. Exp Eye Res. 2012 Oct;103:47-54. doi: 10.1016/j.exer.2012.08.002. Epub 2012 Aug 16.
- Background: PubMed 27713535Zhang Z, Zhou Y, Xie Z, Chen T, Gu Y, Lu S, Wu Z. The effect of topical atropine on the choroidal thickness of healthy children. Sci Rep. 2016 Oct 7;6:34936. doi: 10.1038/srep34936.
- Background: PubMed 26024094Read SA, Alonso-Caneiro D, Vincent SJ, Collins MJ. Longitudinal changes in choroidal thickness and eye growth in childhood. Invest Ophthalmol Vis Sci. 2015 May;56(5):3103-12. doi: 10.1167/iovs.15-16446.
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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.
Alexandra Benavente-Perez, PhD principal investigator
State University of New York College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine in people with Myopia, run by State University of New York College of Optometry 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 5 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 15 Feb 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Choroidal thickness (time frame: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement). 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 NCT03544827, which also lists 19 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 15 Feb 2019.