Sarasota, FLNCT05438732Now EnrollingIRB Ready

Age-Related Macular Degeneration Clinical Trial in Sarasota, FL

Access cutting-edge age-related macular degeneration treatment through this clinical trial at a research site in Sarasota. Study-provided care at no cost to qualified participants.

Sponsored by VisionCare, Inc.

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Expert Care in Sarasota

Access age-related macular degeneration specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related age-related macular degeneration treatment provided free

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Check if you qualify for this age-related macular degeneration clinical trial in Sarasota, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Sarasota

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Sarasota site if eligible
  4. 4Begin participation

About This Age-Related Macular Degeneration Study in Sarasota

The objective of this study is to determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD).

Sponsor: VisionCare, Inc.

Who Can Participate

Inclusion Criteria

Be at least 65 years of age at the Pre-operative Visit;
Have ETDRS BCDVA 0.9 to 1.6 logMAR (20/160 to 20/800) at the Pre-operative Visit caused by bilateral central scotomas associated with end-stage AMD;
Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by standard of care fluorescein angiography (FA) prior to the Pre-operative Visit;
Have been monitored by an eye care professional over the 6-month (or longer) period immediately prior to the Pre-operative Visit and have demonstrated no evidence of active choroidal neovascularization (CNV) prior to the Pre-operative Visit as demonstrated by the following:
lack of need of treatment for CNV over the past 6 months, and
lack of active exudative fluid on optical coherence tomography (OCT) over the past 6 months, and
lack of Retinal hemorrhage on exam over a 6-month period or longer
Agree to participate in post-operative visual training For the Implanted Eye:
Have evidence of visually significant cataract at the Pre-operative Visit;
Agree to undergo pre-operative training and assessment (1 or more sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope model sufficient for patient assessment and patient must achieve at least a 5-letter ETDRS BCDVA improvement (0.1 logMAR) in the final assessment For the Non-Implanted Eye:
Have adequate peripheral vision at the Pre-operative Visit to allow navigation

Exclusion Criteria

Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device;
Have any of the following conditions at the Pre-operative Visit:
Stargardt macular dystrophy;
Diabetic retinopathy;
Untreated retinal tears;
Retinal vascular disease;
Optic nerve disease;
History of retinal detachment;
Intraocular tumor;
Retinitis pigmentosa;
History of steroid-induced rise in intraocular pressure (IOP), uncontrolled glaucoma, or IOP \>22 mmHg at the Pre-operative Visit;
Have known allergy to post-operative medications;
History of eye rubbing or an ocular condition that predisposes subject to eye rubbing;
Have had prior or expected ophthalmic surgery within 30 days of the Operative Visit;
Have any circumstance that, based on the Investigator's judgment, poses a concern for the subject's safety;
Any systemic disease or clinical evidence of any condition at the Pre-operative Visit which would make the subject in the opinion of the investigator unsuitable for the study;
Concurrent participation or prior participation in any investigative drug or device study within last 30 days prior to Pre-operative Visit For the Implanted Eye:
Have central anterior chamber depth (ACD) \<3.0 mm from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline lens at the Pre-operative Visit;
Have an Endothelial Cell Density (ECD) below:
2,000 cells per millimeter, if 65-84 years old;
1,800 cells per millimeter, if 85 years old or greater (based on the lowest value of the three cell counts performed by technician at investigative site at the Pre-operative Visit)
Have a history of corneal stromal or endothelial dystrophies, including guttata;
Have Myopia \> 6.0 D or Hyperopia \> 4.0 D by Manifest Refraction at the Pre-operative Visit;
Have an Axial Length (AL) \< 21 mm at the Pre-operative Visit;
Have a narrow angle defined as \< grade 2 on the Schaffer scale at the Pre-operative Visit;
Ongoing Inflammatory ocular disease at the Pre-operative Visit;
Zonular weakness/instability of crystalline lens, or pseudoexfoliation at the Pre-operative Visit;
Have any condition at the Pre-operative Visit which in the judgement of the Investigator indicates that the haptics cannot be placed within the capsular bag during surgery;
Have had previous intraocular or corneal surgery, including any type of surgery for refractive or therapeutic purposes; For the Non-Implanted Eye:
Have ophthalmic pathology at the Pre-operative Visit that compromises the patient's peripheral vision based on the Investigator's judgment.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Sarasota?

Yes, this clinical trial (NCT05438732) has an active research site in Sarasota, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Age-Related Macular Degeneration Treatment Options in Sarasota, FL

If you're searching for age-related macular degeneration treatment options in Sarasota, FL, this clinical trial (NCT05438732) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Sarasota research site is actively enrolling participants for this clinical trial. You'll receive care from experienced age-related macular degeneration specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all age-related macular degeneration clinical trials near you to find additional studies recruiting in your area.

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