500 Participants Needed

Laser Retinopexy for Stickler Syndrome

(OSC/SS Trial)

PJ
FL
Overseen ByFive Lakes Clinical Research Consultants, LLC
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Helen Keller Eye Research Foundation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a laser procedure in preventing retinal detachment in individuals with Stickler Syndrome (SS), a genetic condition that can cause serious vision problems. Participants will receive a non-invasive laser treatment called Prophylactic Laser Retinopexy in one or both eyes and will undergo regular eye tests over five years to monitor outcomes. This study is open to individuals diagnosed with Stickler Syndrome type 1 or 2 through genetic testing. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance future treatment options for Stickler Syndrome.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the prophylactic laser retinopexy procedure is safe for Stickler Syndrome?

Research shows that the laser treatment under study, called prophylactic laser retinopexy, is usually well-tolerated. This treatment can significantly reduce the risk of retinal detachment in people with Stickler Syndrome. Simply put, it helps keep the retina, the part of the eye that senses light, in place, which is crucial for maintaining clear vision.

While some studies show strong benefits, not all agree on its effectiveness. However, substantial evidence suggests it can help prevent retinal issues without causing major side effects.

As with any medical procedure, risks exist. Overall, this treatment is considered a safe option for many people with Stickler Syndrome.12345

Why are researchers excited about this trial?

Researchers are excited about prophylactic laser retinopexy for Stickler Syndrome because it offers a non-invasive approach to potentially prevent retinal detachment, a common complication of the condition. Unlike traditional surgical methods, this laser treatment is less invasive and aims to strengthen the retina by creating small, controlled burns to form scar tissue, securing it in place. This could significantly reduce the risk of vision loss without the need for more intrusive procedures, making it a promising option for children, adolescents, and adults with Stickler Syndrome.

What evidence suggests that this procedure is effective for preventing retinal detachment in Stickler Syndrome?

Research has shown that prophylactic laser retinopexy can significantly reduce the risk of retinal detachment in individuals with Stickler Syndrome. This trial will administer the laser treatment to participants to assess its effectiveness. One study found that patients who received this treatment were much less likely to experience retinal detachment than those who did not. Another study reported that eyes treated with laser retinopexy had vision approximately eight lines better on an eye chart compared to untreated eyes. Additionally, this laser treatment was associated with a 93% decrease in the likelihood of retinal detachment. These findings suggest that laser retinopexy effectively prevents retinal problems in people with Stickler Syndrome.12467

Who Is on the Research Team?

RE

Robert E Morris, MD

Principal Investigator

Helen Keller Eye Research Foundation

PJ

Peter J Belin, MD

Principal Investigator

Retina Consultants of Minnesota

Are You a Good Fit for This Trial?

This trial is for individuals of any age with Stickler Syndrome (SS) types 1 or 2, confirmed by genetic testing. They must be eligible for a non-invasive eye procedure called prophylactic laser retinopexy and able to give consent. Legal guardians can consent for those who cannot.

Inclusion Criteria

I have signed, or my legal representative has signed, the consent form for this research.
I am eligible for preventive laser eye treatment.
I can sign and understand the consent form.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the OSC/SS prophylactic laser retinopexy procedure in one or both eyes

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the OSC/SS procedure

5 years
9 visits (in-person) over 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Prophylactic (non-invasive) Laser Retinopexy
Trial Overview The study tests if the OSC/SS prophylactic laser retinopexy can prevent retinal detachment in SS patients compared to its natural progression. Participants will undergo this eye procedure, regular eye exams, possible genetic testing, and follow-up visits over five years.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Children, Adolescents, and Adults with SS treated with Prophylactic Laser RetinopexyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Helen Keller Eye Research Foundation

Lead Sponsor

Five Lakes Clinical Research Consulting, LLC

Collaborator

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/21466760/
The clinical effectiveness and safety of prophylactic retinal ...The aim of this systematic review was to assess the evidence for the clinical effectiveness and safety of primary prophylactic interventions for the prevention ...
Laser prophylaxis for retinal detachment in Stickler ...Prophylactic laser therapy was associated with a significantly lower risk of RD in patients with Stickler syndrome compared to no laser ...
Laser Prophylaxis in Patients with Stickler SyndromePurpose: To evaluate the association among laser prophylaxis treatment, retinal detachment (RD), and visual acuity (VA) in patients with Stickler syndrome ...
Laser Prophylaxis in Patients with Stickler SyndromeEyes that received EVBL treatment had approximately 8 lines better vision, on average, compared with those that did not receive laser or NPL treatment (−0.86 ...
Rhegmatogenous Retinal Detachment in Stickler SyndromeLaser retinopexy was associated with a 93% reduction in the odds of RRD (OR 0.07, 95% CI 0.03–0.14), while cryotherapy resulted in a 96% ...
Retinal Detachment Prevention (Laser Prophylaxis) in ...A statistical review of pertinent articles concluded that prophylactic laser therapy was associated with a significantly lower risk of retinal detachment in ...
Laser Prophylaxis in Patients With Stickler SyndromeSome evidence suggests that prophylactic treatment can reduce retinal detachments (RDs) in patients, but study findings are inconsistent.
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