Trial Outcomes & Findings for A Study Raindrop Near Vision Inlay in Presbyopes Implanted in Corneal Pockets (NCT NCT03326869)
NCT ID: NCT03326869
Last Updated: 2020-08-10
Results Overview
After the inlay procedure, patients will attain functional near acuity in the inlay eye and functional distance vision binocularly.
TERMINATED
NA
2 participants
24 Months
2020-08-10
Participant Flow
Participant milestones
| Measure |
Delayed
Intervention: Raindrop Near Vision Inlay
In the delayed approach, the corneal pocket is created and dissected but the corneal inlay is not implanted. After one to three months, the corneal inlay is implanted on a second surgical day.
Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems.
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Non-Delayed
Intervention: Raindrop Near Vision Inlay
In the non-delayed approach, the corneal pocket is created and inlay implanted on the same surgical day.
Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems.
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Overall Study
STARTED
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1
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1
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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1
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1
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Reasons for withdrawal
| Measure |
Delayed
Intervention: Raindrop Near Vision Inlay
In the delayed approach, the corneal pocket is created and dissected but the corneal inlay is not implanted. After one to three months, the corneal inlay is implanted on a second surgical day.
Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems.
|
Non-Delayed
Intervention: Raindrop Near Vision Inlay
In the non-delayed approach, the corneal pocket is created and inlay implanted on the same surgical day.
Raindrop Near Vision Inlay: The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems.
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Overall Study
Study data has been lost to natural disa
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1
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1
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Baseline Characteristics
A Study Raindrop Near Vision Inlay in Presbyopes Implanted in Corneal Pockets
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 24 MonthsPopulation: Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report
After the inlay procedure, patients will attain functional near acuity in the inlay eye and functional distance vision binocularly.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report
Patients implanted with a delayed approach will have minimal incidence of corneal reaction as compared with non-delayed implantation.
Outcome measures
Outcome data not reported
Adverse Events
Delayed
Non-Delayed
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place