The Influence of Atropine on Choroidal Thickness
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 10/17/2018 |
| Start Date: | March 15, 2017 |
| End Date: | November 20, 2017 |
Atropine eye drops are increasingly prescribed for the management of progressive myopia or
short-sightedness. A previous study suggested that the back of the eye or choroid may be a
part of the mechanism by which it induces its effects.
The aim of this study is to characterize the effects of atropine on choroidal thickness and
the influence of time of administration (am vs pm). It is hypothesized that the atropine's
effect on choroidal thickness will vary with baseline thickness related to diurnal rhythm,
where thicker baseline thickness will show a reduced choroidal response.
short-sightedness. A previous study suggested that the back of the eye or choroid may be a
part of the mechanism by which it induces its effects.
The aim of this study is to characterize the effects of atropine on choroidal thickness and
the influence of time of administration (am vs pm). It is hypothesized that the atropine's
effect on choroidal thickness will vary with baseline thickness related to diurnal rhythm,
where thicker baseline thickness will show a reduced choroidal response.
Atropine eye drops are increasingly prescribed for the management of progressive myopia or
short-sightedness. A previous study suggested that the back of the eye or choroid may be a
part of the mechanism by which it induces its effects. The choroid shows diurnal variation
and the efficacy of atropine on myopia control in relationship to the patient's baseline
choroidal thickness is unknown. Thus, the objective of this study is to provide data to
characterize the influence of atropine on choroid thickness. The study aims are to:
1. Determine the effect of am or pm atropine application on choroid thickness
2. Determine the effect of atropine on choroid thickness in relationship to baseline
thickness
Participants will be asked to attend a screening session and 13 study visits. Following the
screening visit, participants will be scheduled to return for 4 visits across 12 hours (4
hour intervals starting from 8am) in a single day where eye shape measurements will be taken
to characterize diurnal variations in eye shape.
Subjects will then be randomized to receive a drop of 1% atropine eye drops in both eyes in
the morning or a night. Measurements of the shape of the front and back of the eye will be
taken after approximately 1, 12, 24 and 96 hours after drop instillation. After a 2 week
washout period, 1% atropine eye drops will be administered either in the morning or at night
(the visit that was not previously scheduled) and measurements of the shape of the front and
back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop
instillation.
short-sightedness. A previous study suggested that the back of the eye or choroid may be a
part of the mechanism by which it induces its effects. The choroid shows diurnal variation
and the efficacy of atropine on myopia control in relationship to the patient's baseline
choroidal thickness is unknown. Thus, the objective of this study is to provide data to
characterize the influence of atropine on choroid thickness. The study aims are to:
1. Determine the effect of am or pm atropine application on choroid thickness
2. Determine the effect of atropine on choroid thickness in relationship to baseline
thickness
Participants will be asked to attend a screening session and 13 study visits. Following the
screening visit, participants will be scheduled to return for 4 visits across 12 hours (4
hour intervals starting from 8am) in a single day where eye shape measurements will be taken
to characterize diurnal variations in eye shape.
Subjects will then be randomized to receive a drop of 1% atropine eye drops in both eyes in
the morning or a night. Measurements of the shape of the front and back of the eye will be
taken after approximately 1, 12, 24 and 96 hours after drop instillation. After a 2 week
washout period, 1% atropine eye drops will be administered either in the morning or at night
(the visit that was not previously scheduled) and measurements of the shape of the front and
back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop
instillation.
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of ocular surgery, including refractive surgery
- Amblyopia
- Use of ocular medications
- Known allergies or sensitivity to atropine
- Pregnant, plan to become pregnant, or are breastfeeding
- Taking monoamine oxidase inhibitors (MAOIs)
We found this trial at
1
site
33 West 42nd Street
New York, New York 10036
New York, New York 10036
Phone: 212-938-5937
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