UnknownPhase 4

A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopic Patients With Treatments to Optimize the Ocular Surface Before Implantation

United States40 participantsStarted 2017-04-10

Plain-language 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.

Who can participate

Age range

41 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

.1.1 Patients require a near reading add from +1.5 to +2.5 D in the non-dominant eye.
.1.2 Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye.
.1.3 Patients have a corneal thickness greater than or equal to 500 microns in the non-dominant eye.
.1.4 Patients have corrected distance and near visual acuity of 20/25 or better in each eye.
.1.5 Patients have distance corrected near visual acuity of 20/40 or worse in each eye.
.1.6 Patients are willing and able to sign and understand a written Informed Consent Form prior to any study-specific procedures.
.1.7 Patients are willing and able to return for scheduled follow-up examinations for 24 months after the corneal inlay surgery.

Exclusion criteria

.2.1 Patients with prior ocular surgery. 1.2.2 Patients with clinically significant dry eye (i.e., significant diffuse punctate staining with fluorescein and a tear breakup time less than 8 s) in either eye.
.2.3 Patients with a planned corneal residual bed thickness that is less than 300 microns (corneal thickness - (intended ablation depth + intended flap thickness)).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Uncorrected Visual Acuity

Timeframe: 24 Months

Trial details

NCT IDNCT03126877

SponsorWhitten Laser Eye

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09

Contact for this trial

Shilpa D Rose, MD

(301) 461-4372 shilpadrose@gmail.com

View on ClinicalTrials.gov More Presbyopia trials