Research Program at Vance Thompson Vision

Vance Thompson Vision is currently recruiting for the following studies. The descriptions below highlight which patients within your program might be good candidates for the treatment types currently under investigation by Vance Thompson Vision and monitored by the FDA. For questions about any of these trials please call our Director of Research Keeley Puls at 605.371.7075

 

Cataract Research

 

RxSight LAL Extended Depth of Focus (EDF) - Currently On Hold

On Hold - Sioux Falls

Good Candidate:  Subjects 40-80 years old who have cataracts in both eye and have interest in trying to achieve the ability to see far away, at an intermediate distance, and at a near distance after LAL implantation

About study:  the purposes of this study are: (1) to evaluate the safety and effectiveness of the LAL to improve intermediate and near uncorrected vision while maintaining distance vision in patients who have been treated with an “extended depth of focus” and (2) to evaluate the safety of LAL implantation and LDD treatments on a patient’s second eye without first assessing all the possible effects of the UV exposure on the first eye.

How long is study:  6-12 months

Number of visits: Up to 12 study visits.

Cost to patient: You will be provided all study related examinations and procedures at no cost. The investigational IOL and the other IOL will be provided at no cost.The costs of your cataract extraction surgery and other standard examinations conducted on all cataract surgery patients will be billed to you or to your insurance company. Depending upon your insurance you may have co-pays for those office visits and surgery.

Compensation:  up to a maximum of $525. Payment made via a Mastercard.

Co-management-  No co-management

Lead Contact- Gabrielle Malmanger elle.malmanger@vancethompsonvision.com 605-371-7083

 

Johnson & Johnson Ancora TIOL-205-STPA Study 

Enrolling- Sioux Falls

Good Candidate:  Subjects at least 22 years old who have cataracts in both eye and have a certain degree of astigmatism in at least one eye.

About study:  The purpose of this study is to evaluate the rate of bothersome visual symptoms and ongoing safety of the TECNIS Symfony Toric Extended Range of Vision intraocular lenses (IOLs).

How long is study:  6 months

Number of visits: a minimum of 9 study visits

Cost to patient: The IOLs implanted will be provided at no cost. Subject and/or  insurance company are responsible for the cost of your regular medical care as well as all usual and customary costs related to your cataract surgeries and any glasses or contacts that may be needed postoperatively. 

Compensation:  Subjects will be compensated for their participation in this study.

Co-management:  No co-management

Lead Contact- Brooke Colby [email protected] 605-371-7068

 

Glaucoma Research

Equinox CP-019 Goggle Study for Glaucoma

Enrolling- Sioux Falls

Good Candidate:Patients 40 years and older with glaucoma.

About study: The MPD (MERCURYTM MULTI-PRESSURE DIAL) is an investigational medical device to lower eye pressure in patients with glaucoma

Which eye:  Both eyes

How long is study:  1 year study

Number of visits:  9 visits, 3 visits are overnights

Cost to patient:  None

Compensation:   You may receive up to $5,000.00 for being in the study. You will be paid per completed visit.

Co-management:  No co-management

Sioux Falls Lead Contact- Jason Meyer [email protected]   605-371-7064

Glaukos GC-010 phase III FDA monitored clinical trial 

Enrolling - Sioux Falls, Fargo, Bozeman, Omaha

Good Candidate: Patients that are ocular hypertensive or have mild to moderate glaucoma and will not need cataract surgery in the next three years or have had cataract surgery and no prior glaucoma surgery.

About study: To compare the safety and initial efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, USP, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Which eye:  Only one eye is eligible to participate in the study

How long is study:  3 year study

Number of visits:  16 visits over the 3 years

Cost to patient:  None

Compensation:  Subjects will be compensated for their participation in this study.

Co-management:  May co-manage non study eye if patient desires but we will watch both during the duration of the study as well.

Sioux Falls Lead Contact- Kristin Dunne [email protected]    605-371-7037 

OR Allie Winter [email protected] 605-371-8440

Fargo Lead Contact:  Sarah Thiede [email protected] 701-566-5525 

Omaha Lead Contact:   Megan Boltjes  [email protected] 402-506-9969 

Bozeman Lead Contact:  Briana Parker [email protected]   406-219-0344

 

Allergan Bitmatoprost

Enrolling - Sioux Falls

 

Good Candidate:  Subjects  at least 18 years of age with a diagnosis of open angle glaucoma or ocular hypertension (high eye pressure) in your study eye that require eye pressure lowering medicine,  that in your study doctor’s opinion,is not adequately managed with topical medication due to side effects

About study:  The purpose of this study is to look into the safety and duration of effect of two dose strengths (10 μg and 15 μg) of Bimatoprost Sustained Release (SR) in the treatment ofglaucoma or ocular hypertension (high eye pressure).

How long is study:  approximately 32 months

Number of visits: there will be a total of 36 study visits over a period of approximately 32 months (includes up to a 10 day screening

period, up to a 42 day washout period, 18 months of a study treatment period followed by 12 months of extended follow up)

Cost to patient: It is not expected for there to be any costs for subjects  taking part in this study

Compensation:  Subjects will be compensated for their participation in this study.

Co-management-  No co-management

Lead Contact- Allie Winter [email protected]  605-371-7077

 

Sight Sciences Omni-Gemini 

Enrolling - Omaha, Fargo, Bozeman

Good Candidate: Patients 22 years of age and older with visually significant cataracts and open angle glaucoma.

About study: The purpose of this study is to assess the clinical effect of two procedures, performed using the OMNI Surgical System, and cataract surgery on eye pressure and glaucoma medications for people with glaucoma.

Which eye:   One eye

How long is study: 1 year

How many visits:  9 visits, possibly more

Cost to patient:  You or Your insurance will be billed for the study procedure, OMNI surgery + Cataract removal. All exams and tests that are required under this study and described in this consent form will be paid for by the study sponsor

Compensation:   Subjects will be compensated for their participation in this study.

Co-management:  No co-management

Fargo Lead Contact:  Sarah Thiede [email protected] 701-566-5525

Omaha Lead Contact:   Megan Boltjes  [email protected] 402-506-9969

 

Aphakic Research

None at this time.

Presbyopic Research

None at this time.

Refractive Research

Carl Zeis MEL 90-2018-1

Enrolling - Sioux Falls

Good Candidate: Patients 18 years of age and older with hyperopia.

  • We are specifically looking for the following....
  • Hyperopia up to +6.00D with astigmatism up to -4.00D
  • Mixed Astigmatism with Hyperopia up to +3.75D and Astigmatism up to -4.00D

About study: The purpose of this study is to evaluate the safety and effectiveness of the MEL 90 Excimer Laser in performing LASIK ( Laser assisted in situ keratomileusis) for reshaping the cornea.

Which eye: One or both eyes in study.

How long is study: 1 year study

Number of visits: 9+ visits over 1 year. Each visit lasting 1-2 hours

Cost to patient: No cost to the patient.

Compensation:  No compensation but subject receives the procedure at no cost.

Co-management-  No co-management

Lead Contact- Sam Nielson  [email protected]     605-371-7049

 

STAAR ICL

Enrolling - Fargo (Sioux Falls done enrolling)

Good Candidate: persons 21 through 45 years of age and have nearsightedness (myopia) with or without astigmatism.

About study:The purpose of the study is to scientifically evaluate whether use of EVO/EVO+ lenses, when used without making a hole in the iris, is reasonably safe and effective..

Which eye: Both eyes in study.

How long is study: 43 months

Number of visits: 11 visits over the 43 months

Cost to patient: you will not have to pay for study lenses, any study visits, exams or tests that are part of standard of care for ICL surgery. You may have to pay for part of the surgical procedure. If so, you (or your insurance company) may be billed for the standard part of the surgical procedure. It is unlikely that your insurance company will pay for this charge because this is an elective procedure and you are in a research study

Compensation:  Compensated Up to $450 fpr completed visits. (plus no charge for study lenses, study visits or exams.)

Co-management-  No co-management

Lead Contact- Sarah Thiede sarah.thiede@vancethompsonvision.com     701-639-2017

 

 

Johnson & Johnson Monovision

Enrolling - Sioux Falls

 

Good Candidate: Persons at least 40 years of age at enrollment who have myopia (nearsightedness) with or without astigmatism and presbyopia (reduction in focusing ability for near work)

About study: The iDesign system and a STAR S4 IR® Excimer laser System are currently approved as safe and effective for LASIK treatment of myopia with and without astigmatism. The device will be used to plan for and to perform the LASIK treatment.

Which eye: Both eyes

How long is study: 12 months

Number of visits: 8 scheduled study visits.

Cost to patient: Patient will be billed the costs of the procedure (which includes pre-operative examination, LASIK procedure, post-operative visits, usual physician fees, or other procedures required for treatment and follow-up). **Patient receives 25% off the commercial price of LASIK.

Compensation:  Up to $400 paid at end of study.

Co-management-  No co-management

Lead Contact- Whitney Oehlerts [email protected]vancethompsonvision.com     605-371-7042

          

Dry Eye Research

 

None at this time.

 

 

Cornea Research

Avedro Cross Linking ACP-KXL-401

Enrolling- Fargo, Bozeman, (Sioux Falls done enrolling)

Good Candidate:   at least 18 years of age, have corneal ectasia after refractive surgery (such as LASIK, PRK, and planning to have corneal collagen cross-linking, or had cross-linking within the past 90 days.

About Study:  You may be eligible to take part in this observational registry study because you have been diagnosed with corneal ectasia after refractive surgery (such as LASIK or PRK) and you are planning, or have had, corneal collagen cross-linking procedure performed

Which eye:   One or both eyes

How long is study: 3 years

How many visits:  7 visits over 36 months.

Cost to patient:  You or your medical insurance company may be required to pay up to $6,750.00 for the cost of the treatment, medications prescribed by the study doctor during the course of the study, and for any additional standard medical care given during this research study.

Compensation: Subjects will be compensated for their participation in this study.

Co-management:   No co-management

Fargo Lead Contact: Sarah Thiede [email protected] 701-566-5525

Bozeman Lead Contact: Briana Parker [email protected]   406-219-0344

 

 

Aerie (Fuchs Corneal Dystrophy) 

Enrolling - Sioux Falls

Good Candidate:    Patients who have been diagnosed with corneal edema due to Fuchs Corneal Dystrophy in one or both of your eyes

About Study: The purpose of this research study is to test the safety and treatment effects of two dosing schedules of netarsudil ophthalmic solution 0.02% (netarsudil) in subjects with corneal edema due to Fuchs Corneal Dystrophy.

Which eye:  Both eyes are eligible to participate in the study

How long is study:  8 weeks

How many visits: 5 visits

Cost to patient: There will be no charge for participation in this study. The study drug (netarsudil), artificial tears, study-related procedures, and study visits will be provided at no charge to you or your insurance company.

Compensation:  $50 per completed visit

Co-management:  No co-management

Lead Contact: Samantha Nielson [email protected] 605-371-7049

HEADACHE RESEARCH

None at this time.

 

closed to enrollment - ongoing studies

  • Alcon LASIK RFP911-C001 - Currently On Hold

  • Ora Oyster Point OPP-101 (Dry Eye)

  • Olympia TEAR Care System (Dry Eye)

  • EyeGate OBG-PE-042 (Dry Eye)

  • Allergan Presbyopia

  • RxSight LAL

  • Johnson & Johnson Bravo

  • Acufocus

  • EyeGate PRK (Refractive)

  • Sjogrens Dry Eye

  • Carl Zeiss Monofocal IOL

  • B+L Dvisc

  • B&L - Viscosurgical Device
  • Alcon UV-Femtosecond Laser Assisted Lenticular Extraction
  • Glaukos - GC-009
  • Glaukos - GC-007
  • Teton
  • Denali
  • Glaukos - PAS
  • Sonata 2
  • Alcon Toric IOL, ORA
  • Artisan Aphakia Lens
  • Advedro Crosslinking - Sioux Falls
  • Glaukos GC-011
  • DES/iStent
  • Alcon LASIK PFP911-C001
  • STAAR ICL
  • Bausch & Lomb 884 Teneo