Bausch & Lomb 945

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/Lens Studies

Bausch & Lomb 945

Location ~ Sioux Falls

Good Candidate: Subjects who have a cataract in each eye which has caused their vision to worsen.

About Study: The purpose of this research study is to evaluate the safety and effectiveness of the B+L enVista Hydrophobic One-piece Trifocal Intraocular Lens in subjects who receive this IOL in both eyes.

Which eye:  Both Eyes

How long is study: 1 year

How many visits: At least 11 visits

Cost to patient: The cost of surgery will NOT be paid by Bausch + Lomb. Subject/or subject insurance provider will be responsible for the cost of the surgery. Bausch + Lomb will provide the study intraocular lens or lenses at no cost.

Compensation: Subject compensated up to $590 for completed visits.

Co-management: No co-management

Lead Contact: Whitney Oehlerts [email protected], 605-371-7042


RxSight Light Adjustable Lens Extended Depth of Focus (EDF) (RxSight 033) (CURRENTLY PAUSED TO ENROLLMENT)

Location~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 [email protected], 605-371-7083


IIT~ PanOptix (TrIPLe) Study

Location~SIOUX FALLS and Fargo

Good Candidate: Subject who have had previous LASIK and are at least 3 months post op PanOptix implantation

About study:  The purpose of this study is to determine if preoperative IOL calculations, including Barrett TK, Barrett Universal II, Hill RBF, ASCRS post-refractive calculator, or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.

How long is study:  3 months

Number of visits: 2

Cost to patient: No cost to be in study. Patient is responsible for standard surgical costs.

Compensation: $100

Co-management:  Yes

Lead Contact Sioux Falls: Elle Malmanger [email protected] 605-371-7083

Lead Contact Fargo: Sarah Thiede [email protected], 701-639-2017 or Jake Hutchison [email protected], 701-388-0381



 

IIT~ VIVity Outcomes in PAtients with Early Stage Glaucoma

Location~SIOUX FALLS

Good Candidate: Subjects at least 45 years of age who have been previously diagnosed with early stage (pre-perimetric) glaucoma and visually significant cataracts and plan to have bilateral cataract surgery and are being implanted with a Vivity or Vivity Toric IOL

About study:  To determine the visual outcomes in patients with mild, pre-perimetric glaucoma who undergo cataract surgery with implantation of the Alcon Vivity Extended Range Intraocular Lens (IOL).

How long is study:  6 months

Number of visits: 1 visits

Cost to patient: Subjects will receive $2000 off upgraded package per eye.

Compensation: Once post-op visit complete, subject receives $200 in form of a check.

Co-management:  Yes

Lead Contact: Whitney Oehlerts [email protected], 605-371-7042


IIT~ Long Term Outcomes of Vivity IOL versus Control (REVIVE STUDY)

Location~SIOUX FALLS

Good Candidate: All the subjects will be recruited from the subjects that were previously enrolled in the original Vivity FDA clinical trial

About study:  The purpose of this study is to Evaluate the long-term (>1 yr) outcomes of the Vivity IOL.

How long is study: 1 day

Number of visits: 1 visit

Cost to patient: No cost

Compensation: $100

Co-management: Yes

Lead Contact: Whitney Oehlerts [email protected] 605-371-7042


GLAUCOMA


Qlaris QC-202

Location~Sioux Falls

Good Candidate: Subjects 18 years of age or older who have Normal Tension Glaucoma

About Study: The primary objective of this clinical trial is to evaluate theocular and systemic safety and tolerability of 2 concentrations of QLS-101 compared to timolol maleate ophthalmic solution.

Which eye: Only one eye enrolled in study

How long is study: 15 days, potentially longer if wash out of medication is needed

How many visits: 6 visits

Cost to patient: There are no anticipated additional costs

Compensation: Up to $600 for completed visits

Co-management: No co-management

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


Equinox CP-019 Goggle Overnight Study for Glaucoma 

Locations~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 iStent inject #IG2M-105-PASN

Locations~Sioux Falls, Bozeman, Fargo, Omaha, Alexandria


Good Candidate: Patients diagnosed with mild to moderate open-angle glaucoma, taking medications to control the eye pressure in your eye, and have been determined to have a cataract which requires surgery.

About study: The purpose of this study is to assess the long-term safety of an approved (by FDA) medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.

Which eye: One eye enrolled in study

How long is study: 3 year study

Number of visits: 9-10 visits

Cost to patient: You will not be charged for study-related visits before and after surgery. You and your insurance will be billed in the usual manner for the costs of the cataract surgery, stent surgery, medications, and additional follow-up visits your study doctor may require that are standard of care.

Compensation: You will be paid up to $975 for completed visits if it is decided that you quality for the study.

Co-management: No co-management

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

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

Fargo Lead Contact: Sarah Thiede [email protected] 701-639-2017

Omaha Lead Contact: Sarah Hartnett [email protected] 402-899-8020


Allergan Bitmatoprost-

Location~Sioux Falls

 

Good Candidate: Subjects with glaucoma or ocular hypertension (high eye pressure)

About study: The purpose of this study is to look into the safety and duration of effect of Bimatoprost Sustained Release (SR) 10 μg in the treatment of glaucoma

glaucoma 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:  Subject receives UP TO $700 depending on number of visits.

Co-management: No co-management

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


Santen ANGEL-2 Study

Location~Fargo

 

Good Candidate: Subjects 18 years or older who have received a diagnosis of POAG or OHT

About study: The purpose of this study is to see how safe and effective an investigational study dug (eye drop) is and how well it will work to treat Primary Open-Angel Glaucoma (POAG) or Ocular Hypertension (OHT).

How long is study:  5 month

Number of visits: Up to 5 visits

Cost to patient: The study drug, study-related procedures, and tests, and study visits will be provided at no cost to you. The sponsor, Santen, pays for them

Compensation:  $150.00 for each completed visit. If all 5 visits completed, a total of &750

Co-management:  No co-management

Lead Contact: Sarah Thiede [email protected] 701-639-2017


PRESBYOPIC

 

Novartis Presbyopia Drop Stud UNR844

Location~Sioux Falls

 

Good Candidate:   Subjects ages 45 to 55 years who have presbyopia (trouble reading and seeing things up close due to getting older)

About Study: The purpose of the study is to find out what is the best dose of UNR844 to improve near vision of people with Presbyopia.

Which eye: Both eyes

How long is study: 1year

How many visits: Up to 15 visits.

Cost to patient: You will not have to pay for any study treatment(s) or any study-related tests while you are in the study.

Compensation: $150 per completed visit; up to

Co-management: No co-management

Lead Contact: [email protected] 605-361-7083


DRY EYE

 

Sight Sciences Dry Eye-SAHARA

Location~Sioux Falls

Good Candidate:   Subjects at least 22 years of age who Report having dry eye symptoms within the past 3 to 6 months and having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms

About Study: To demonstrate the safety and effectiveness of TearCare® treatments compared to Restasis® to treat the signs and symptoms of dry eye disease in adult patients

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

How long is study: 24 months

How many visits: 13 visits

Cost to patient: You will not have to pay for your study treatment(s) or any of the tests and procedures done for study purposes

Compensation:  Up to $850 for completed visits.

Co-management: No co-management

Lead Contact: Jason Meyer [email protected] 605-361-7064


CORNEA RESEARCH

 

TreFoil Therapeutics TTHX-002

Locations ~ Sioux Falls, Fargo, Bozeman, Omaha

Good Candidate: Subjects 18 years of age or older who have a Fuchs Endothelial Cell Dystrophy (FECD)

About Study: The primary objective of this clinical trial is to evaluate the safety and efficacy of TTHX1114 in the setting of DWEK/DSO.

Which eye:  Only one eye enrolled in study

How long is study:  1 year

How many visits: 9-12 visits

Cost to patient: There are no anticipated additional costs

Compensation: Up to $825 for completed visits

Co-management:  No co-management

Sioux Falls Lead Contact: Elle Malmanger [email protected] 605-361-7083

Fargo Lead Contact: Sarah Thiede [email protected] 701-639-2017

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

Omaha Lead Contact: Sarah Hartnett [email protected] 402-899-8020

 

Avedro Cross Linking ACP-KXL-401

Locations~Fargo and Bozeman

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: 5-7 visits over 36 months. (subjects may enroll at month 3)

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: Subject will be compensated up to $600.00.

Co-management:   No co-management

Fargo Lead Contact: Sarah Thiede [email protected] 701-639-2017

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

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



 

REFRACTIVE

 

STAAR ICL PAS (CP18-02)

Locations ~ FARGO

Good Candidate: Subjects with Myopia

About study: The FDA has asked STAAR Surgical Company to conduct a study with the Visian Toric ICL to collect additional information on the performance of the lens.

Which eye: Both eyes

How long is study: 27 months

Number of visits: 11 visits

Cost to patient: $500/eye

Compensation: $230/eye for completed visits

Co-management:  No co-management

Lead Contact: Jake Hutchison [email protected] 701-388-0381


Johnson & Johnson Monovision

Location 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: Subjects will pay $1000 per eye. (This is a $2000 discount per eye)

Compensation:  $400 at end of study

Co-management: No co-management

Lead Contact: Whitney Oehlerts [email protected]     605-371-7042


Carl Zeiss MEL 90-2018-1

Location~SIOUX FALLS 

 
  • We are specifically looking for the following....

  • Hyperopia up to +5.00D with or without astigmatism up to +4.00D

  • Mixed Astigmatism  up to +4.00D 

  • Myopes with high cyl -3 to -4

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

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


AnchorAPHAKIC RESEARCH

None at this time


Studies in Follow-Up (Done enrolling)


IIT~ RxSight Defocus Curve

Location~SIOUX FALLS

Good Candidate: Patients who plan to (1) undergo bilateral implantation with the commercial LAL and (2) receive binocular custom vision are eligible for study participation

About study:  The objective of this study is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL).

How long is study:  3 months

Number of visits: 2 visits

Cost to patient: No cost to be in study. Patients responsible for standard surgical costs.

Compensation: $750

Co-management:Yes


Equinox CP-022

Location~Sioux Falls

Good Candidate: Subjects ages 22 years or older with severe open-angle glaucoma (OAG).

About study: This research study is being done to learn if the MPD can safely lower eye pressure in patients with severe open-angle glaucoma (OAG). The MPD is an investigational medical device to lower eye pressure in patients with glaucoma.

Which eye:  Both eyes

How long is study: 1 visit study

Number of visits: 1, possibly 2 visits (screening may be done on a different day)

Cost to patient: There are no additional costs associated with being in this study. You are responsible for your regular health care while in this study.

Compensation: Patients will receive up to $250 for participating. Patients residing 50 miles or more from the study site will be compensated an additional $50.00 to cover the increased travel expense

Co-management: No co-management

 

 

Aerie (Fuchs Corneal Dystrophy) AR-13324-CS210

Locations ~ Sioux Falls, Fargo

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

 

 

J&J Ancora TIOL-205-STPA Study 

Location~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:  Subject receives up to $300-450 in a form of a visa gift card.

Co-management: No co-management

 

 

Glaukos GC-010 (iDose Phase III) 

Locations~Sioux Falls, Omaha, Fargo and Bozeman

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: 19 visits over the 3 years

Cost to patient:  None

Compensation: Patient receives  $1,425. Subjects will not be charged for the Idose or timolol.

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


Glaukos EXPAND IDOS-106-EXCH

Locations~Sioux Falls

Good Candidate: Subjects who were previously implanted with the Travoprost Intraocular Implant in the GC-009 study (1st Cycle).

About study: The study objective is to evaluate the safety of the surgical exchange procedure of Travoprost Intraocular Implant in subjects with a previously implanted

Travoprost Intraocular Implant that reduces high eye pressure (intraocular pressure) in patients with open-angle glaucoma (OAG) or high eye pressure.

Which eye:  Both eyes

How long is study: 1 year study

Number of visits:  8 visits

Cost to patient: You will not be charged for study-related visits before and after surgery. You and your insurance will be billed in the usual manner for the costs of the cataract surgery, stent surgery, medications, and additional follow-up visits your study doctor may require that are standard of care.

Compensation: You will be paid up to $600 if it is decided that you quality for the study.

Co-management: No co-management





 

STAAR ICL (Sioux Falls)

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



 

Alcon Lasik RFP911-C001 (Sioux Falls)

Good Candidate: Persons at least 18 years of age and have nearsightedness (myopia) with or without astigmatism.

About study: The purpose of this research study is to obtain information on the safety and effectiveness of the WaveLight EX500 laser using InnovEyes along with eye measurements from the InnovEyes sightmap to correct refractive errors for the reduction or elimination of nearsightedness

Which eye: Both eyes in study.

How long is study: 13 months

Number of visits: 9 visits over the 13 months

Cost to patient: Participation in this study will result in no extra costs to you. You or your insurance company may be billed for any standard medical care given during this research study

Compensation: Compensated Up to $335 for completed visits.

Co-management: No co-management


Bausch and Lomb 884 Teneo (Sioux Falls)

Good Candidate: At least 22 years or older and have myopia or myopic astigmatism.

About study:The purpose of this research study is to evaluate the safety and effectiveness of laser vision correction using the TENEO 317 Model 2 excimer laser.

Which eye: Both eyes in study.

How long is study: 1 year study

Number of visits: 8 visits over 1 year.

Cost to patient: No cost to the patient.

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

Co-management:  No co-management