PresbyopiaPhase 4NCT03376412
A Study to Evaluate the Raindrop Near Vision Inlay Under Flap or Within Pocket
A Phase 4 study testing Raindrop Near Vision Inlay in people with Presbyopia, run by Whitten Laser Eye at 1 site in United States.
Trial summary
The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopes implanted under a corneal flap or within a small-incision pocket. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- Raindrop Near Vision Inlay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2017to Dec 2020
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.1.1 Patients require a near reading add from +1.5 to +2.5 D in the non-dominant eye.
- 1.1.2 Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye.
- 1.1.3 Patients have a central corneal thickness ≥ 500 microns in the non-dominant eye.
- 1.1.4 Patients have corrected distance and near visual acuity of 20/25 or better in each eye.
- 1.1.5 Patients have uncorrected near acuity of 20/40 or worse in the non-dominant eye.
- 1.1.6 Patients are willing and able to understand and sign a written Informed Consent Form prior to any study-specific procedures.
- 1.1.7 Patients are willing and able to return for scheduled follow-up examinations for 24 months after corneal inlay implantation.
Who cannot join
- 1.1.1 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.
- 1.1.2 Patients with a planned corneal residual bed thickness that is less than 250 microns (corneal thickness - (intended flap thickness + intended ablation depth)).
- 1.1.3 Patients with macular pathology based on dilated fundus exam and/or optical coherence tomography (OCT) image.
- 1.1.4 Patients who would be co-managed by an ophthalmologist or optometrist who is not approved as a ReVision Optics investigator.
- 1.1.5 Patients with ocular pathology or disease (including pupil pathology such as fixed pupils) that might confound the outcome or increase the risk of adverse event.
- 1.1.6 Patients taking systemic or topical medications that might confound the outcome or increase the risk of adverse event. Patients taking isotretinoin or amiodarone hydrochloride and any other medication that affects the tear film or accommodation, including but not limited to, mydriatic, cycloplegic and mitotic agents, tricyclic, phenothiazines, benzodiazepines, and first generation antihistamines.
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- 1.1.7 Patients with known sensitivity to any planned study medications. 1.1.8 Patients with residual, recurrent, active or uncontrolled eyelid disease. 1.1.9 Patients with significant corneal asymmetry or irregular topography. 1.1.10 Patients with clinically significant anterior segment pathology. 1.1.11 Patients with any corneal abnormality, including but not limited to, slit lamp findings for corneal staining Grade 3 or higher, recurrent corneal erosion or severe basement membrane disease, and pterygium extending onto the cornea.
- 1.1.12 Patients with ophthalmoscopic/topographic signs of keratoconus or those who are keratoconus suspect.
- 1.1.13 Patients with history of Herpes zoster or Herpes simplex keratitis. 1.1.14 Patients with any progressive retinal disease or patients with a history or evidence of retinal vascular occlusion and/or hypercoagulability, because of the risks associated with high pressures during suction application.
- 1.1.15 Patients with known history of steroid-responsive intraocular pressure increases, glaucoma, preoperative IOP > 21 mm Hg, or are otherwise suspected of having glaucoma.
- 1.1.16 Patients with amblyopia or strabismus or those who are at risk for developing strabismus postoperatively as determined by corneal light reflex and cover-uncover testing.
- 1.1.17 Patients with diabetic retinopathy, collagen, vascular, diagnosed autoimmune disease (e.g., lupus, rheumatoid arthritis, fibromylagia), immunodeficiency (e.g., HIV), connective tissue disease, or clinically significant atopic syndrome such as allergies or asthma.
- 1.1.18 Patients on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing.
- 1.1.19 Patients with any type of active cancer (ophthalmic or non-ophthalmic). 1.1.20 Patients with uncontrolled infections of any kind. 1.1.21 Patients who are pregnant, lactating, of child-bearing potential and not practicing a medically approved method of birth control, or planning to become pregnant during the course of the trial, and patients with other conditions associated with fluctuation of hormones that could lead to refractive changes.
- 1.1.22 Patients who actively participate in contact sports (i.e., boxing, martial arts) where impacts to the face and eye are a normal occurrence.
- 1.1.23 Patients participating in any other ophthalmic or non-ophthalmic drug/device clinical trials during the time of this clinical investigation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Whitten Laser Eye
Washington D.C., District of Columbia, 20016
Shilpa D Rose, MD, 301-461-4372, shilpadrose@gmail.com
Shilpa D Rose, MD
About this study
Official title: A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Implanted Under a Corneal Flap or Within a Small-Incision Pocket
The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopes implanted under a corneal flap or within a small-incision pocket.
Read the detailed description
Patients must require a reading add from +1.5 to +2.5 D, and both emmetropes as well as ametropes (requiring concurrent LASIK) are included in the investigation. Suitable patients will undergo implantation of the Raindrop inlay in the non-dominant eye to improve near vision. If necessary, a LASIK excimer ablation will first be performed to optimize postoperative vision at near and distance. Patients will follow a one-month regimen of strong steroid, at a minimum, after corneal inlay implantation to facilitate healing and visual recovery.
- Conditions
- Presbyopia
- Being tested
- Raindrop Near Vision Inlay
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raindrop Near Vision InlayDevice
A maximum of 60 consecutive non-dominant eyes will be implanted with the Raindrop Near Vision Inlay.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Treatment. | Experimental | All patients will be unilaterally implanted in the non-dominant eye with the Raindrop Near Vision Inlay for the compensation of presbyopia. Receives: Device: Raindrop Near Vision Inlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Visual Acuity
After the inlay procedure, patients will attain functional near acuity in the inlay eye and functional distance vision binocularly.
Measured: 24 Months
Secondary outcomes (1)
Incidence of Corneal Reaction
Patients implanted either under a corneal flap or within a small-incision pocket will have minimal incidence of corneal reaction.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start8 Dec 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will be a prospective, single-center, open label clinical trial where a maximum of 60 consecutive non-dominant eyes are implanted with the Raindrop Near Vision Inlay.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Whitten Laser Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark E. Whitten, MD, Principal investigator, Whitten Laser Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376412
- Sponsor's protocol ID
- SDR2017-004
- Status last verified
- Dec 2017
- First submitted
- 13 Dec 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Implanted Under a Corneal Flap or Within a Small-Incision Pocket
- ClinicalTrials.gov ID
- NCT03376412
- Acronym / sponsor ID
- SDR2017-004
- Conditions
- Presbyopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Whitten Laser EyeUniversity, hospital or other
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Dec 2017 (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.
The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopes implanted under a corneal flap or within a small-incision pocket.
Detailed description
Patients must require a reading add from +1.5 to +2.5 D, and both emmetropes as well as ametropes (requiring concurrent LASIK) are included in the investigation. Suitable patients will undergo implantation of the Raindrop inlay in the non-dominant eye to improve near vision. If necessary, a LASIK excimer ablation will first be performed to optimize postoperative vision at near and distance. Patients will follow a one-month regimen of strong steroid, at a minimum, after corneal inlay implantation to facilitate healing and visual recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will be a prospective, single-center, open label clinical trial where a maximum of 60 consecutive non-dominant eyes are implanted with the Raindrop Near Vision Inlay.
| Arm | Type | Receives |
|---|---|---|
| Single Arm Treatment. | Experimental | Device: Raindrop Near Vision InlayAll patients will be unilaterally implanted in the non-dominant eye with the Raindrop Near Vision Inlay for the compensation of presbyopia. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1.1.1 Patients require a near reading add from +1.5 to +2.5 D in the non-dominant eye.
- 1.1.2 Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye.
- 1.1.3 Patients have a central corneal thickness ≥ 500 microns in the non-dominant eye.
- 1.1.4 Patients have corrected distance and near visual acuity of 20/25 or better in each eye.
- 1.1.5 Patients have uncorrected near acuity of 20/40 or worse in the non-dominant eye.
Key exclusion criteria (16 listed)
- 1.1.1 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.
- 1.1.2 Patients with a planned corneal residual bed thickness that is less than 250 microns (corneal thickness - (intended flap thickness + intended ablation depth)).
- 1.1.3 Patients with macular pathology based on dilated fundus exam and/or optical coherence tomography (OCT) image.
- 1.1.4 Patients who would be co-managed by an ophthalmologist or optometrist who is not approved as a ReVision Optics investigator.
- 1.1.5 Patients with ocular pathology or disease (including pupil pathology such as fixed pupils) that might confound the outcome or increase the risk of adverse event.
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 |
|---|---|---|
| Raindrop Near Vision InlayA maximum of 60 consecutive non-dominant eyes will be implanted with the Raindrop Near Vision Inlay. | Device | Single Arm Treatment. |
Primary outcome
Uncorrected Visual Acuity
Time frame: 24 Months
After the inlay procedure, patients will attain functional near acuity in the inlay eye and functional distance vision binocularly.
1 secondary outcome
Incidence of Corneal Reaction
Time frame: 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Mark E. Whitten, MD principal investigator
Whitten Laser Eye
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 Raindrop Near Vision Inlay in people with Presbyopia, run by Whitten Laser Eye 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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 18 Dec 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shilpa D. Rose, MD ((301) 461-4372, shilpadrose@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Visual Acuity (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2017.