PresbyopiaPhase 4NCT03242317
A Prospective Study to Evaluate the Raindrop Near Vision Inlay With Mitomycin C
A Phase 4 study testing Mitomycin C and Raindrop Near Vision Inlay in people with Presbyopia, run by Fichte, Endl & Elmer Eyecare 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 treated with low dose, short duration Mitomycin C (MMC) during surgery and an extended low dose steroid regimen after surgery. Read more about this study
- Who is it for?
- Ages 41 to 65 years
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2017to 1 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 41 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients require a near reading add from +1.5 to +2.5 D in the non-dominant eye.
- Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye. Patients have a corneal thickness greater than or equal to 500 microns in the non-dominant eye.
- Patients have corrected distance and near visual acuity of 20/25 or better in each eye.
- Patients have distance corrected near visual acuity of 20/40 or worse in each eye.
- Patients are willing and able to sign and understand a written Informed Consent Form prior to any study-specific procedures.
- Patients are willing and able to return for scheduled follow-up examinations for 24 months after the corneal inlay surgery.
Who cannot join
- Patients with prior ocular surgery. 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.
- Patients with a planned corneal residual bed thickness that is less than 300 microns (corneal thickness - (intended ablation depth + intended flap thickness)).
- Patients with macular pathology based on dilated fundus exam and/or optical coherence tomography (OCT) image.
- Patients who would be co-managed by an ophthalmologist or optometrist who is not approved as a ReVision Optics investigator.
- 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.
- 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.
Show all 16Show fewer
- Patients with known sensitivity to any planned study medications. Patients with residual, recurrent, active or uncontrolled eyelid disease. Patients with significant corneal asymmetry or irregular topography. Patients with clinically significant anterior segment pathology. 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.
- Patients with ophthalmoscopic/topographic signs of keratoconus or those who are keratoconus suspect.
- Patients with history of Herpes zoster or Herpes simplex keratitis. 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.
- Patients with known history of steroid-responsive intraocular pressure increases, glaucoma, preoperative IOP > 21 mm Hg, or are otherwise suspected of having glaucoma.
- 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.
- 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.
- Patients on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing.
- Patients with any type of active cancer (ophthalmic or non-ophthalmic). Patients with uncontrolled infections of any kind. 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.
- Patients who actively participate in contact sports (i.e., boxing, martial arts) where impacts to the face and eye are a normal occurrence.
- 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
Fichte Endl & Elmer Eyecare
Amherst, New York, 14228
Micheal J Endl, MD, 716-564-2020, mpderme@aol.com
About this study
Official title: A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Treated With Mitomycin C During Surgery and Extended Steroid After Surgery
The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopes treated with low dose, short duration Mitomycin C (MMC) during surgery and an extended low dose steroid regimen after surgery.
Read the detailed description
The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket. In the third month after surgical procedure, one-drop a day of low dose steroid will be continued for the duration of the 24-month follow-up period to maintain corneal health.
- 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
The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket.
Raindrop Near Vision InlayDevice
The surgical procedure includes the unilateral implantation of the Raindrop Near Vision Inlay in the non-dominant eye for the improvement of uncorrected near vision.
| Study group | Role | What they receive |
|---|---|---|
| Mitomycin C + Raindrop Near Vision Inlay | Experimental | The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the Raindrop Near Vision Inlay in Presbyopes. 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 (1)
Incidence of Corneal Reaction
Patients treated with low dose, short duration MMC intraoperatively, then an extended low dose steroid regimen will have minimal levels 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 posted8 Aug 2017
- Study start16 Jun 2017
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Dec 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fichte, Endl & Elmer Eyecare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Endl, MD, Principal investigator, Fichte, Endl & Elmer Eyecare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242317
- Sponsor's protocol ID
- FEE17-001
- Status last verified
- Aug 2017
- First submitted
- 3 Aug 2017
- Last updated
- 8 Aug 2017
- 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 8 Aug 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 Treated With Mitomycin C During Surgery and Extended Steroid After Surgery
- ClinicalTrials.gov ID
- NCT03242317
- Acronym / sponsor ID
- FEE17-001
- Conditions
- Presbyopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fichte, Endl & Elmer EyecareUniversity, hospital or other
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 8 Aug 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 treated with low dose, short duration Mitomycin C (MMC) during surgery and an extended low dose steroid regimen after surgery.
Detailed description
The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket. In the third month after surgical procedure, one-drop a day of low dose steroid will be continued for the duration of the 24-month follow-up period to maintain corneal health.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitomycin C + Raindrop Near Vision Inlay | Experimental | Drug: Mitomycin C, Device: Raindrop Near Vision InlayThe surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the Raindrop Near Vision Inlay in Presbyopes. |
Who may qualify
- Ages
- 41 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients require a near reading add from +1.5 to +2.5 D in the non-dominant eye.
- Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye. Patients have a corneal thickness greater than or equal to 500 microns in the non-dominant eye.
- Patients have corrected distance and near visual acuity of 20/25 or better in each eye.
- Patients have distance corrected near visual acuity of 20/40 or worse in each eye.
- Patients are willing and able to sign and understand a written Informed Consent Form prior to any study-specific procedures.
Key exclusion criteria (16 listed)
- Patients with prior ocular surgery. 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.
- Patients with a planned corneal residual bed thickness that is less than 300 microns (corneal thickness - (intended ablation depth + intended flap thickness)).
- Patients with macular pathology based on dilated fundus exam and/or optical coherence tomography (OCT) image.
- Patients who would be co-managed by an ophthalmologist or optometrist who is not approved as a ReVision Optics investigator.
- 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.
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 CThe surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket. | Drug | Mitomycin C + Raindrop Near Vision Inlay |
| Raindrop Near Vision InlayThe surgical procedure includes the unilateral implantation of the Raindrop Near Vision Inlay in the non-dominant eye for the improvement of uncorrected near vision. | Device | Mitomycin C + Raindrop Near Vision Inlay |
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.
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 8 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
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.
Michael J Endl, MD principal investigator
Fichte, Endl & Elmer Eyecare
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 Mitomycin C and Raindrop Near Vision Inlay in people with Presbyopia, run by Fichte, Endl & Elmer Eyecare 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 6 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 8 Aug 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 Michael J Endl, MD ((716) 564-2020, mpderme@aol.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 8 Aug 2017.