Clinical Trials

Current Clinical Trials

This is a list of our current clinical trials actively recruiting subjects. Click on a Study Title to learn more! Full trial descriptions can be found on ClinicalTrials.gov, or via research pipeline pages on study sponsor websites.

[su_spoiler title=”General Ophthalmology” style=”default” icon=”plus-circle”]

Zoster Eye Disease Study (ZEDS) – Enrollment CLOSED

Brief Summary:
This randomized, controlled clinical trial will determine if prolonged, suppressive dosing at 1000mg valacyclovir daily for one year reduces complications of HZO, including chronic eye disease and post-herpetic neuralgia, when compared to placebo. This study is co-sponsored by NYU Langone and the National Eye Institute – National Institute of Health, and is looking to enroll over 1000 participants at 60+ participating clinical centers, including Northwest Eye Surgeons.

For more information, visit these links:
https://clinicaltrials.gov/ct2/show/NCT03134196?cond=Herpes+Zoster&phase=23&fund=0&rank=3
https://med.nyu.edu/research/zoster-eye-disease-study/zoster-eye-disease-study

PI: Audrey Talley Rostov, MD ; Sub-I’s: Dr. Kerri Svanda and Dr. Stacey Keppol
Location: Seattle Northgate Clinic

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[su_spoiler title=”Refractive” style=”default” icon=”plus-circle”]

VisuMax SMILE Satisfaction Study (Zeiss)

Brief Summary:
This is a observational post-approval study for subjects who are undergoing bilateral SMILE treatment for the reduction or elimination of myopia with astigmatism (spherocylindrical refractive error). Subjects will complete a vision questionnaire pre-op and at 6 months post-op. It is important that subjects who enroll are willing and able to return for the 6 month study visit. Subject compensation is set at $100 for the pre-op visit, and $400 for the 6 month post-op visit.

The questionnaire is based off the PROWL-SS and will evaluate visual symptoms (double images, glare, halos, and starbursts), dry eye symptoms, satisfaction with vision pre and post op, and satisfaction with regards to the SMILE surgery.

Eligible Participants:
Age: 22 and older with spherocylindrical refraction
Good candidate for SMILE treatment OU, with stable MR over past 12 months
SMILE can treat myopia up to 10.0D, and astigmatism up to 3.0D
SMILE treatment must be for myopia and astigmatism, with target of plano OU
Fluent English speaking and reading
Willing and able to return for 6-month postoperative examination

Exclusion Criteria:
Abnormal corneal findings, or residual bed thickness less than 250 microns
Signs of progressive or unstable myopia, or suspicion of keratoconus
Hx of severe dry eye, active infection or inflammation, or chronic recurring conditions
Hx of previous refractive surgery

For more information, visit these links:
https://www.nweyes.com/smile/
https://www.zeiss.com/meditec/int/products/refractive-lasers/femtosecond-laser-solutions/visumax.html

PI: Audrey Talley Rostov, MD ; Sub-I’s: Dr. Kerri Svanda and Dr. Shikha Yadav
Location: Seattle Northgate Clinic and Surgery Center

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[su_spoiler title=”Cornea” style=”default” icon=”plus-circle”]

Observational Study to Assess Durability of KXL for Post-Refractive Corneal Ectasia

Brief Summary:
This is a Phase 4 Observational registry to evaluate (36 months) long-term safety and efficacy of KXL treatment in patients with Post-Refractive Corneal Ectasia. Changes in Pentacam Ks, Endo Cell Count, and BCVA are the main study parameters. Enrollment will start with a pre-procedure screening appointment and the KXL procedure in the study eye. Post-procedure study visits are scheduled for 3M, 6M, 12M, 24M, and 36M. Subject’s medical insurance will be billed for the KXL procedure and for the duration of the study. Potential subject compensation is $600.

Eligible Participants:
Age: 18 and older
Diagnosis of Post-Refractive Surgery (LASIK or PRK) Corneal Ectasia
Good candidate for KXL treatment in Investigator’s medical opinion

Exclusion Criteria:
Pregnant or lactating at time of enrollment

For more information, visit these links:
https://clinicaltrials.gov/ct2/show/NCT03319082?cond=corneal+ectasia&draw=2&rank=2\

PI: Audrey Talley Rostov, MD ; Sub-I’s: Dr. Kerri Svanda and Dr. Stacey Keppol
Location: Seattle Northgate Clinic

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[su_spoiler title=”Cataracts” style=”default” icon=”plus-circle”]

Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants

***Enrollment will be closing soon***

Brief Summary:
This is an IIT Study sponsored by Dr. Satish Modi (Seeta Eye Center) and is a Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants. Eligible patients will have randomized, bilateral cataract surgery with either the TECNIS® Synergy lenses or the AcrySof IQ PanOptix® lenses. We’re looking for patients that are good candidates for a Non-Toric Spherical Multifocal IOL, with clear media other than cataracts, without prior history of LASIK or PRK, and with good vision outcome potential! The lens is being provided by the study sponsor, and is at no cost to the subject. Study Visits are post-op at 1M, 3M, and 6M and include UCVA and BCVA at all distances, defocus curve, and contrast senstivity assessments.

Eligible Participants:
Age: 22 and older
Plan to have bilateral CE w/ IOL ; surgeries to be performed 1 week apart
Minimal astigmatism, up to 0.80D cyl, that can be addressed with CCI’s
Clear intraocular media other than cataracts

Exclusion Criteria:
History of prior refractive surgery
Plan for multiple procedures (ex. MIGS)
Surgeon’s opinion regarding subject’s candidacy for MF IOL

For more information, visit these links:
https://www.clinicaltrials.gov/ct2/show/NCT05186298?term=multifocal&cond=Cataract&cntry=US&state=US%3AWA&draw=2&rank=3

PI: Audrey Talley Rostov, MD ; Sub-I’s: Dr. Kerri Svanda and Dr. Stacey Keppol
Location: Seattle Northgate Clinic and Surgery Center

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[su_spoiler title=”Glaucoma” style=”default” icon=”plus-circle”]

NCX 470-03 Investigational Eye Drop Clinical Trial (Denali)

Brief Summary:
Northwest Eye Surgeons (Seattle Northgate Clinic) is participating in an international multi-center clinical study to evaluate the safety and efficacy of an investigational eye drop vs. latanoprost in subjects with open angle glaucoma or high eye pressure. This research study involves ~12 office visits over the course of ~12 months

You may be eligible to participate if you are:

1. Age: 18-84 yrs old
2. Have a diagnosis of open angle glaucoma or high eye pressure in both eyes
3. Provide informed consent

If in the opinion of the study doctor you are eligible for the study and enrolled, the sponsor will provide you with:
– Study eye drops at no cost to you
– Periodic study-related examinations and ophthalmologist evaluations
– Potential subject stipend = Approximately $1,575 for your 12-month participation

For more information, visit these links:
https://clinicaltrials.gov/ct2/show/NCT04630808?term=nicox&recrs=abdf&draw=2&rank=2
https://www.nicox.com/pipeline-markets-and-science/#product-ncx-470

PI: Bruce Cameron, MD; Sub-I’s: Drs. Landon Jones, Emily Bucher, and Sarah Henderson
Location: Seattle Northgate Clinic

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OMNI Precision Safety and Efficacy of Higher Volume OMNI (Sight Sciences)

***Not Yet Recruiting***
Activation Anticipated Q3-Q4 2022

For more information, visit these links:
https://www.sightsciences.com/us/sight-sciences-announces-fda-authorization-for-the-precision-trial-a-groundbreaking-three-arm-randomized-controlled-ide-trial/

PI: Bruce Cameron, MD ; Sub-I’s: Michael Banitt, MD and Drs. Landon Jones, Emily Bucher, Sarah Henderson, and Stacey Keppol
Location: Seattle Northgate Clinic and Surgery Center

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Character Genomics – Glaucoma Progression Study (Clover Therapeutics)

Brief Summary:
Character Biosciences is the sponsor of this genomic study to assess how genetics (DNA) may be linked with different types of glaucoma. This is an observational study and with a decentralized study model. We will schedule the call between eligible subject and Character Biosciences. Character Biosciences will obtain the informed consent, HIPAA authorization, release of medical records, and arrange for shipment of a saliva swab kit. Northwest Eye Surgeons is responsible for providing 3-5 years of prior medical history and 5 prospective years of medical history. Subjects will receive a $25 giftcard as appreciation for their participation.

Eligible Participants:
Age: 40 and older
Diagnoses of Primary Open Angle Glaucoma or Low-Tension Glaucoma (all stages)
Willingness to provide informed consent, HIPAA authorization, and release of medical records
VF mean deviation betwen -3 to -18 dB, either eye

Exclusion Criteria:
Glaucoma secondary to eye trauma or other eye disorders
Diagnoses of Congenital Glaucoma, Uveitic Glaucoma, PXE or Pigmentary Dispersion
History of severe diabetic retinopathy, corneal transplant, or uveitis
History of LPI or presence of AC/IOL

For more information, visit these links:
https://www.characterbio.com/

PI: Aaron Kuzin, MD ; Sub-I’s: all NWES glaucoma-managing doctors
Location(s): all sites – decentralized

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[su_spoiler title=”Retina” style=”default” icon=”plus-circle”]

OTT166-201 Diabetic Retinopathy Drop Trial (OcuTerra)

Brief Summary:
OcuTerra has developed OTT166 eye drop application for diabetic retinopathy. “It is designed to be administered by the patient at home and has the potential to dramatically change the treatment paradigm by enabling earlier non-invasive treatment to preserve vision and prevent progression, thereby delaying or completely eliminating the need for intravitreal injections and/or destructive laser procedures.” This Phase 2 study is to evaluate the safety and efficacy of low vs high dosing of OTT166 in moderate-severe NPDR and mild PDR subjects, over 6 months. Potential subject compensation = $800.

Eligible Participants:
Age: 18 and older
Diagnoses of DM1 or DM2, with moderate-severe NPDR or mild PDR
Treatment naive in study eye (i.e. no previous anti-VEGF, steroid, PRP, focal or grid laser, or PPV)
Vision 20/40 or better without significant corneal or retinal disease
Can have had uncomplicated intraocular surgery or Yag Capsulotomy 90+ days prior to enrollment
On stable concomitant use of topical eye drops for 90+ days prior to enrollment

Exclusion Criteria:
HbA1C of more than 10.0% ; intensive insulin treatment within 4 months prior to enrollment
Renal failure, dialysis, or hx of renal transplant
DME that affects center of macula; CST greater than 300
Any significant retinal or corneal conditions, uncontrolled glaucoma or ocular hypertension
Pregnancy, or unwillingness to use approved contraceptive methods
No contact lens use for duration of the study (6 months)

For more information, visit these links:
https://clinicaltrials.gov/ct2/show/NCT05409235?cond=diabetic+retinopathy&draw=2&rank=2
https://www.ocuterratx.com/pipeline

PI: Paul Griggs, MD ; Sub-I’s: Dr. Richard Lee
Location: Seattle Northgate Clinic

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[su_spoiler title=”Past Studies” style=”default” icon=”plus-circle”]

• Travoprost Intraocular Implant Clinical Study (Glaukos) | Enrollment Complete
• Idenitification of Bacteria Associated with Blepharitis (Oyster Point) | Enrollment Complete
• Post-Market LAL Outcome Assessment | Enrollment Complete

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