PresbyopiaPhase 4NCT03101501
A Prospective Study To Evaluate The Raindrop Near Vision Inlay In Presybopic or Pseudophakic Patients Treated With Mitomycin C Following Femtosecond Flap Creation.
A Phase 4 study testing Mitomycin c and Raindrop Near Vision Inlay in people with Presbyopia, run by Key-Whitman Eye Center at 3 sites in United States.
Trial summary
The clinical objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopic or pseudophakic patients treated with low dose Mitomycin C immediately following femtosecond flap creation. Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- Mitomycin c and Raindrop Near Vision Inlay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Feb 2017to 1 Feb 2018
- 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 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 4.2.1 Presbyopic patients 41-65 years of age.
- 4.2.2 Pseudophakic patients at least 50 years of age.
- 4.2.3 Patients require a near reading add from +1.50 to +2.50 D in the non-dominant eye.
- 4.2.4 Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye.
- 4.2.5 Patients have a corneal thickness greater than or equal to 500 microns in the non-dominant eye.
- 4.2.6 Patients have corrected distance and near visual acuity of 20/25 or better in each eye.
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- 4.2.7 Patients have distance corrected near visual acuity of 20/40 or worse in each eye.
- 4.2.8 Patients have no more than a 0.75 D difference at preop between MRSE and cycloplegic refraction spherical equivalent determined at the spectacle plane of each eye.
- 4.2.9 Patients have targeted MRSE from -0.5 to +1.0 D in the non-dominant eye, with no more than 0.75 D of manifest cylinder with or without LASIK.
- 4.2.10 Patients are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
- 4.2.11 Pseudophakic patients must be at least 3 months after cataract surgery.
- 4.2.12 Pseudophakic patients must have clear posterior capsule, open posterior capsule (post YAG Capsulotomy), or posterior capsule opacification that is not clinically significant at the opinion of the investigator.
- 4.2.13 Patients are willing and able to return for scheduled follow-up examinations for 24 months after the corneal inlay surgery.
Who cannot join
- 4.3.1 Patients with prior corneal surgery including LASIK surgery in the non-dominant eye. (Not including Astigmatic Keratotomy or Limbal Relaxing Incisions)
- 4.3.2 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.
- 4.3.3 Patients with a planned corneal residual bed thickness that is less than 300 microns (corneal thickness - (intended ablation depth + intended flap thickness)).
- 4.3.4 Patients with clinically significant macular pathology based on dilated fundus exam and/or optical coherence tomography (OCT) image.
- 4.3.5 Patients who would be co-managed by an ophthalmologist or optometrist who is not an approved sub-investigator.
- 4.3.6 Patients with ocular pathology or disease (including pupil pathology such as fixated pupils) that might confound the outcome or increase the risk of adverse event in the investigator's opinion.
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- 4.3.7 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, or any other medications in the investigator's opinion.
- 4.3.8 Patients with known sensitivity to any planned study medications.
- 4.3.9 Patients with residual, recurrent, active or uncontrolled eyelid disease.
- 4.3.10 Patients with significant corneal asymmetry or irregular topography.
- 4.3.11 Patients with clinically significant anterior segment pathology.
- 4.3.12 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.
- 4.3.13 Patients with ophthalmoscopic/topographic signs of keratoconus or those who are keratoconus suspect.
- 4.3.14 Patients with history of Herpes zoster or Herpes simplex keratitis.
- 4.3.15 Pseudophakic patients that have anterior chamber IOLs, multifocal IOLs, or extended range of vision IOLs in either eye.
- 4.3.16 Patients with any progressive retinal disease or subjects with a history or evidence of retinal vascular occlusion and/or hypercoagulability, because of the risks associated with high pressures during suction application.
- 4.3.17 Patients with known history of steroid-responsive intraocular pressure increases, glaucoma, preoperative IOP > 21 mm Hg, or are otherwise suspected of having glaucoma.
- 4.3.18 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.
- 4.3.19 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.
- 4.3.20 Patients on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing at the opinion of the investigator.
- 4.3.21 Patients with any type of active cancer (ophthalmic or non-ophthalmic).
- 4.3.22 Patients with uncontrolled infections of any kind.
- 4.3.23 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.
- 4.3.24 Patients who actively participate in contact sports (i.e., boxing, martial arts) where impacts to the face and eye are a normal occurrence.
- 4.3.25 Patients participating in any other ophthalmic or non-ophthalmic drug/device clinical trials during the time of this clinical investigation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Chu Vision Institue
Bloomington, Minnesota, 55420
Key-Whitman Eye Center
Dallas, Texas, 75243
Parkhurst NuVision
San Antonio, Texas, 78229
About this study
The clinical objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopic or pseudophakic patients treated with low dose Mitomycin C immediately following femtosecond flap creation.
Read the detailed description
The scientific objective of this study is to evaluate the postoperative incidence of corneal reaction in patients treated with low dose Mitomycin C, immediately following femtosecond flap creation (LASIK correction if needed), and before implantation with the Raindrop corneal inlay in the non-dominant eye. The postoperative incidence of haze, visible by broad tangential illumination of the slit lamp, is known to adversely impact the safety and efficacy of the Raindrop corneal inlay. Three main strategies have been employed to minimize haze incidence after surgery: (i) perfection of the surgical technique, (ii) deeper implantation in the cornea, and (iii) extension of the steroid regimen after surgery. Haze has also been observed after another type of corneal refractive procedure, Photorefractive Keratectomy (PRK). Several prospective studies have shown that Mitomycin C, applied immediately following the PRK laser procedure, is effective in reducing the postoperative incidence of haze.
- Conditions
- Presbyopia
- Being tested
- Mitomycin c, 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.
Mitomycin cDrug
Low dose mitomycin C at a concentration of 0.02% will be applied a duration of 10 to 30 seconds at the time of the surgical procedure.
Raindrop Near Vision InlayDevice
Implanted to improve near vision in Presbyopic or Pseudophakic subjects.
| Study group | Role | What they receive |
|---|---|---|
| MMC for fibrosis prevention | Experimental | no intervention is required after procedure is performed Receives: Drug: Mitomycin c; 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 visual acuity in the inlay eye and functional distance acuity binocularly.
Measured: 24 months
Secondary outcomes (2)
Incidence of Corneal Reaction
Patients treated with low dose mitomycin C will have minimal levels of corneal reaction.
Measured: 24 months
Endothelial Cell Count (measured by Konan Specular Microscope)
Patients treated with low dose mitomycin C will not lose more than 10% of their endothelial cell count from the preoperative measurement
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 posted5 Apr 2017
- Study start14 Feb 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Why it stopped: The manufacturing company of the Raindrop Corneal Inlay has stopped distribution or sales of the product.
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Key-Whitman Eye Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Whitman, MD, Key-Whitman Eye Center
- Investigators
- Jeffrey Whitman, M.D., Principal investigator, Key-Whitman Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101501
- Sponsor's protocol ID
- P17-001
- Status last verified
- Aug 2022
- First submitted
- 30 Mar 2017
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. 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 Presybopic or Pseudophakic Patients Treated With Mitomycin C Following Femtosecond Flap Creation.
- ClinicalTrials.gov ID
- NCT03101501
- Acronym / sponsor ID
- P17-001
- Conditions
- Presbyopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The manufacturing company of the Raindrop Corneal Inlay has stopped distribution or sales of the product.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Key-Whitman Eye CenterUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 5 Apr 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 clinical objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopic or pseudophakic patients treated with low dose Mitomycin C immediately following femtosecond flap creation.
Detailed description
The scientific objective of this study is to evaluate the postoperative incidence of corneal reaction in patients treated with low dose Mitomycin C, immediately following femtosecond flap creation (LASIK correction if needed), and before implantation with the Raindrop corneal inlay in the non-dominant eye. The postoperative incidence of haze, visible by broad tangential illumination of the slit lamp, is known to adversely impact the safety and efficacy of the Raindrop corneal inlay. Three main strategies have been employed to minimize haze incidence after surgery: (i) perfection of the surgical technique, (ii) deeper implantation in the cornea, and (iii) extension of the steroid regimen after surgery. Haze has also been observed after another type of corneal refractive procedure, Photorefractive Keratectomy (PRK). Several prospective studies have shown that Mitomycin C, applied immediately following the PRK laser procedure, is effective in reducing the postoperative incidence of haze.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MMC for fibrosis prevention | Experimental | Drug: Mitomycin c, Device: Raindrop Near Vision Inlayno intervention is required after procedure is performed |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 4.2.1 Presbyopic patients 41-65 years of age.
- 4.2.2 Pseudophakic patients at least 50 years of age.
- 4.2.3 Patients require a near reading add from +1.50 to +2.50 D in the non-dominant eye.
- 4.2.4 Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye.
- 4.2.5 Patients have a corneal thickness greater than or equal to 500 microns in the non-dominant eye.
Key exclusion criteria (25 listed)
- 4.3.1 Patients with prior corneal surgery including LASIK surgery in the non-dominant eye. (Not including Astigmatic Keratotomy or Limbal Relaxing Incisions)
- 4.3.2 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.
- 4.3.3 Patients with a planned corneal residual bed thickness that is less than 300 microns (corneal thickness - (intended ablation depth + intended flap thickness)).
- 4.3.4 Patients with clinically significant macular pathology based on dilated fundus exam and/or optical coherence tomography (OCT) image.
- 4.3.5 Patients who would be co-managed by an ophthalmologist or optometrist who is not an approved sub-investigator.
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 |
|---|---|---|
| Mitomycin cLow dose mitomycin C at a concentration of 0.02% will be applied a duration of 10 to 30 seconds at the time of the surgical procedure. | Drug | MMC for fibrosis prevention |
| Raindrop Near Vision InlayImplanted to improve near vision in Presbyopic or Pseudophakic subjects. | Device | MMC for fibrosis prevention |
Primary outcome
Uncorrected Visual Acuity
Time frame: 24 months
After the inlay procedure, patients will attain functional near visual acuity in the inlay eye and functional distance acuity binocularly.
2 secondary outcomes
Incidence of Corneal Reaction
Time frame: 24 months
Endothelial Cell Count (measured by Konan Specular Microscope)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: The manufacturing company of the Raindrop Corneal Inlay has stopped distribution or sales of the product.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- 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.
Jeffrey Whitman, M.D. principal investigator
Key-Whitman Eye Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mitomycin c and Raindrop Near Vision Inlay in people with Presbyopia, run by Key-Whitman Eye Center at 3 sites 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 13 inclusion and 25 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: stopped early, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was stopped early (reason given: The manufacturing company of the Raindrop Corneal Inlay has stopped distribution or sales of the product.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 Aug 2022; AzTrials last refreshed its copy on 30 Oct 2026.