Research
Clinical Research at SightMD
One of the most exciting aspects of medicine is continuous innovation, scientific exploration, and research into how we can provide enhanced care for our patients. The field of ophthalmology has been on the forefront and recipient of revolutionizing technology, novel medications, premium devices, and innovative surgical techniques. Individually or combined, these advancements have provided patients with better vision and improved treatment options.
At SightMD we are continuously coupling efforts with top-tiered patient-centric industry-leading companies to bring the newest techniques, technologies, and medications to our patients through our Department of Clinical Research. Lead by Dr. Alanna Nattis, she has designed, developed, and exclusively accessed investigational treatment studies for wide-ranging ophthalmic conditions such as severe dry eye, glaucoma, refractive and cataract surgery, and retinal pathologies. Having direct access to FDA clinical trials uniquely provides SightMD with state-of-the-art care for our current and future patients.
Ongoing/Currently Enrolling Investigator-Initiated Trial (IIT)
We are currently recruiting for several active clinical trials. Please contact us for more information!
Evaluation of pre-and-perioperative variables on visual outcome and patient satisfaction with trifocal intraocular lens implantation
Real-world trial evaluating visual outcomes as well as visual aberrations post-implantation of the trifocal PanOptix IOL at the time of cataract surgery
- PI: Alanna Nattis, DO
- Sub-I’s: Richard Nattis MD, John Passarelli MD, Jordan Garelick MD, Craig Richter MD, Jeffrey Martin MD
- Sponsor: Alcon
- Presented at the American Society of Cataract and Refractive Surgery meeting
Relief of dry eye signs and symptoms with adjunctive loteprednol etabonate 0.38% eye drops
Real-world trial evaluating dry eye symptom improvement with adjunctive loteprednol eye drops to routine lifitegrast use BID
- PI: Alanna Nattis, DO
- Sub-I’s: Richard Nattis MD
- Sponsor: Bausch & Lomb
Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain – The LINK Study
Evaluation of post-corneal crosslinking pain and inflammation utilizing a dexamethasone intracanalicular insert vs. topical prednisolone
- PI: Alanna Nattis, DO
- Sponsor: Ocular Therapeutix
- Presented at the American Society of Cataract and Refractive Surgery meeting
- Published in the Journal of Cataract and Refractive Surgery
Evaluation of changes in corneal stromal thickness using anterior segment OCT following treatment of neurotrophic ulcers with Oxervate
Imaging study evaluating change in corneal stromal thickness using anterior segment OCT while on topical human recombinant nerve growth factor eye drops
- PI: Brad Kligman MD
- Sponsor: Dompe
Impact of a Novel extended depth of focus intraocular lens on visual and lifestyle enhancement
Real-world trial evaluating visual outcomes as well as visual aberrations post-implantation of the extended depth of focus Vivity IOL at the time of cataract surgery
- PI: Alanna Nattis, DO
- Sub-I’s: Richard Nattis MD, John Passarelli MD, Jordan Garelick MD, Craig Richter MD, Eric Rosenberg DO
- Sponsor: Alcon
- Presented at the American Society of Cataract and Refractive Surgery meeting
Evaluation of Vision Recovery and Comfort Index in Patients with Borderline/Mild Dry Eyes Undergoing Femtosecond Laser-Assisted Cataract Surgery with Premium Intraocular Lens: The ENHANCE Study
Evaluation of visual outcomes and dry eye signs/symptoms post-femtosecond laser cataract surgery with use of intracanalicular dexamethasone insert at the time of surgery
Evaluation in a long-term follow up time frame of the AcrySof single-piece and AcrySof multi-piece monofocal intraocular lenses
- PI: John Passarelli MD
- Sponsor: Ocular Therapeutix
Prospective randomized evaluation and comparison of the effect of decreased illumination on visual recovery following cataract surgery
Evaluation of visual outcomes and signs of cystoid macular edema in patients undergoing cataract surgery using the NGENUITY 3D Cataract Surgery system vs. conventional operative microscope
Long-term evaluation of patients post-bilateral implantation of Clareon Panoptix and/or Vivity intraocular lenses
- PI: Eric Rosenberg DO
- Sponsor: Alcon
- Presented at the American Society of Cataract and Refractive Surgery meeting
- Published in The Journal of Cataract and Refractive Surgery
Intraocular pressure, pachymetry & keratometry assessment utilizing a novel non-invasive device vs. standard-of-care diagnostics
Comparison and validation of standard intraocular pressure, (IOP) keratometry and pachymetry measurements vs. a novel 4-in-1 device that measures IOP, keratometry and pachymetry in a non-contact method in one sitting.
- PI: Alanna Nattis, DO
- Sub-I: Eric Rosenberg DO
- Sponsor: Topcon
FDA Trials
A 4 week, Phase II multicenter, randomized, double-masked, vehicle-controlled, parallel group study with 12 weeks of follow-up to evaluate safety and efficacy of recombinant human Nerve Growth Factor (rhNGF) eye drops solution versus vehicle, in patients with moderate to severe dry eye (DE)
Evaluation of treatment of dry eye with recombinant human nerve growth factor (Oxervate) vs. Vehicle
- PI: Alanna Nattis, DO
- Sub-I: Richard Nattis MD
- Sponsor: Dompe
Prospective, Randomized Phase 3 Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, USP 0.5%
Evaluation of novel device that is implanted in the trabecular meshwork and releases travoprost continuously to lower intraocular pressure in glaucoma patients. Device lasts 3 years
*PIVOTAL Trial – SightMD’s partnership here helped provide positive data that allowed this device to be FDA approved – first of its kind; has revolutionized the way we can treat glaucoma
- PI: Alanna Nattis, DO
- Sub-I’s: Richard Nattis MD, Raju Sarwal MD
- Sponsor: Glaukos
Digital Health Suite Pilot Retrospective Optimization Study (DHSPROS)
Retrospective identification of patients having undergone monofocal and toric intraocular lens implantation for a novel software to help make cataract surgery planning more efficient
- PI: Alanna Nattis, DO
- Sub-I: Richard Nattis MD
- Sponsor: Alcon
A phase 2, Multicenter, Randomized Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray in subjects with Neurotrophic Keratopathy (The Olympia Study)
Evaluation of novel varenicline nasal spray in subjections with early stage neurotrophic keratopathy
- PI: Alanna Nattis, DO
- Sub-I: Eric Rosenberg DO
- Sponsor: Oyster Point Pharmaceuticals
A Long-term Safety Study Evaluating Safety and Systemic Exposure of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-4)
Evaluation of safety and efficacy of novel cold-receptor modulator eye drop to help treat dry eye
*PIVOTAL Trial: Drop is now FDA approved
- PI: Brad Kligman MD
- Sponsor: Aerie Pharmaceuticals
Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Safety and Efficacy of Nyxol (Phentolamine Ophthalmic Solution 0.75%) as a Single Agent and With Adjunctive Low-Dose Pilocarpine Hydrochloride Ophthalmic Solution 0.4% in Subjects With Presbyopia
Evaluation of safety and efficacy of phentolamine eye drops for treatment of presbyopia
- PI: Jeffrey Martin MD
- Sponsor: Ocuphire
(Phase 4) A Real World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses
Evaluation of visual outcomes in patients with Alcon monofocal and monofocal toric intraocular lenses
- PI: Alanna Nattis, DO
- Sub-I: Eric Rosenberg DO
- Sponsor: Alcon
(Phase 4) Long-term evaluation of safety and performance of Clareon Presbyopia-Correcting IOLs—PMCF Study of Clareon Vivity & Clareon Panoptix
Evaluation of visual outcomes in patients with bilaterally implanted Alcon Clareon Panoptix and Vivity intraocular lenses
- PI: Alanna Nattis, DO
- Sub-I: Eric Rosenberg DO
- Sponsor: Alcon
(Phase 4) Demodex Blepharitis Longitudinal Real-World Patient Journey Study
Evaluation of symptomatic improvement and use of adjunctive medical treatment for patients with diagnosis of demodex blepharitis – from both the provider and patient side (survey-based study in addition to documentation of clinical findings)
- PI: Alanna Nattis, DO
- Sub-I: Eric Rosenberg DO
- Sponsor: Tarsus
A Multicenter, Randomized, Double-masked, placebo-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Subcutaneously Administered Pozelimab in Combination with Cemdisiran or Cemdisiran Alone in Participants with Geographic Atrophy Secondary to Age-Related Macular Degeneration
Novel study evaluating effect of systemic C5 inhibition on geographic atrophy (GA) lesion growth over 1 year as well as measures of functional disease progression
*PIVOTAL Trial: Unique Phase 3 trial utilizing a novel treatment method for GA, rather than observation and intravitreal injections. Has potential to change the way GA and macular degeneration is treated as a whole.
- PI: Edward Marcus, MD
- Sponsor: Regeneron
Randomized, Placebo-Controlled Double-Masked Study of the Safety and Efficacy of POS (0.75% Phentolamine ophthalmic solution) in subjects who have previously had keratorefractive surgery and have decreased visual acuity under mesopic conditions (Phase 3)
Evaluation of symptomatic improvement of visual disturbances and improvement in visual acuity in patients who had previously undergone keratorefractive surgery (LASIK, PRK)
- PI: Jeffrey Martin MD
- Sponsor: Oculos
(Phase 4) A Non-interventional, observational study to evaluate treatment patterns and safety of avacincaptad pegol (ACP/IZERVAY) in routine clinical practice in patients with geographic atrophy secondary to age-related macular degeneration
Evaluation of treatment patterns and safety of Izervay in routine clinical practice (“real world study”) for the treatment of geographic atrophy (GA) secondary to age related macular degeneration (AMD)
- PI: Edward Marcus MD
- Sponsor: Astellas Pharma
A Phase 3 Randomized, Multi-center, placebo-controlled, masked study to evaluate the clinical efficacy and safety of Fucithalmic (Fusidic Acid) Viscous Topical Antibiotic Eye Drops for the treatment of suspected bacterial conjunctivitis
Evaluation of outcomes for patients with confirmed bacterial conjunctivitis following treatment with BID Fucithalmic (novel antibiotic to the US, widespread use with excellent broad spectrum activity noted outside of the US).
- PI: Alanna Nattis DO
- Sub-I: Eric Rosenberg DO
- Sponsor: Baxis Pharmaceuticals
(Phase 4) An Observational real-world evidence study of Ab-Interno Goniotomy performed using the C-REX™ Instrument in patients with primary open angle glaucoma (The Circle Registry)
Evaluation of outcomes for patients in a real-world setting after surgery with the C-REX ™ Goniotomy instrument in patients with primary open angle glaucoma, as characterized by change in intraocular pressure, use of ocular hypotensive medications, ocular adverse events
- PI: Raju Sarwal MD
- Sponsor: Iantrek
(Phase 4): A 12-month Retrospective Study Evaluating Real-world evidence of the safety and effectiveness of the STREAMLINE Surgical system (the VERONA Study)
Retrospective evaluation of patient outcomes following treatment with the STREAMLINE surgical system for glaucoma
- PI: Raju Sarwal MD
- Sponsor: New World Medical