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Intraocular Implant

Optimized Ocular Surface for Presbyopia

Phase 4
Waitlist Available
Led By Shilpa D Rose, MD
Research Sponsored by Whitten Laser Eye
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopic patients with treatments to optimize the ocular surface before corneal inlay surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Uncorrected Visual Acuity
Secondary outcome measures
Incidence of Corneal Reaction
Ocular Surface Health (Preoperative Optimization)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Optimized Ocular SurfaceExperimental Treatment2 Interventions
For patients enrolled into the treatment group for preoperative optimization of the ocular surface, utilize the LipiFlow® vectored thermal pulsating eyepieces (Activators) to gently apply heat and massage, thus evacuating the Meibomian glands. Omega-3 vitamin supplements should also be provided, initiated and dosed according to standard clinical practice, to maximize ocular surface health.
Group II: Non-Optimized Ocular SurfaceActive Control2 Interventions
Patients enrolled into the non-treatment group will not be optimized preoperatively for ocular surface health. No LipiFlow® Activators and no Omega-3 vitamin supplements will be provided, initiated, nor dosed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitomycin
FDA approved

Find a Location

Who is running the clinical trial?

Whitten Laser EyeLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Presbyopia
60 Patients Enrolled for Presbyopia
Shilpa D Rose, MDPrincipal InvestigatorWhitten Laser Eye

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopic Patients With Treatments to Optimize the Ocular Surface Before Implantation
2017. "A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopic Patients With Treatments to Optimize the Ocular Surface Before Implantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03126877.
All > Vision
~5 spots leftby Apr 2025
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