62 Participants NeededMy employer runs this trial

Atropine for Eye Conditions

(APPRAISE Trial)

JS
Overseen ByJay Stewart, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether atropine eyedrops aid recovery after certain eye surgeries, specifically vitrectomy surgery, which removes the gel inside the eye. Participants will either use the atropine drops or not (control group) to determine if the drops affect healing. This study targets individuals about to undergo vitrectomy surgery who can consent to participate. However, those using certain anti-inflammatory eyedrops or with an allergy to atropine cannot join. The goal is to determine if atropine can improve post-surgery outcomes. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if your post-surgery eyedrop regimen includes certain anti-inflammatory medications.

What is the safety track record for atropine?

Studies have shown that atropine eye drops are generally safe. Approved for children as young as three months, they assist with eye exams or certain eye conditions. However, like most medications, they can cause side effects, such as eye irritation, larger pupils, and, in rare cases, allergic reactions. Some individuals might also experience a fast heartbeat or dry skin.

Atropine has been used safely in various eye treatments for many years. Discussing any concerns with a healthcare provider can help determine if this treatment is suitable.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about atropine eye drops for eye conditions because they offer a potentially new approach to slowing the progression of myopia (nearsightedness). Unlike standard treatments like corrective lenses or laser surgery, atropine works by acting on the muscarinic receptors in the eye, which helps to slow down the elongation of the eyeball—a key factor in worsening myopia. This unique mechanism of action could provide a non-invasive alternative to traditional methods, offering hope for more effective management of myopia progression. Additionally, atropine eye drops are easy to use, making them a convenient option for ongoing treatment, especially in children and adolescents.

What evidence suggests that atropine eyedrops might be an effective treatment for eye conditions?

Research has shown that atropine eye drops effectively treat eye conditions, particularly in controlling nearsightedness (myopia). Studies indicate that low doses, such as 0.05%, can significantly slow the progression of myopia. For example, one study found that children using 0.05% atropine experienced less eye growth over a year compared to those using a lower dose. Another study discovered that using 0.05% atropine drops nightly delayed the onset of myopia in young children. In this trial, participants in the experimental arm will use atropine eye drops, while those in the control arm will not receive atropine. These findings suggest that atropine can effectively manage certain eye conditions and may also benefit patients after eye surgeries.678910

Who Is on the Research Team?

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Jay Stewart, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for people who are having vitrectomy eye surgery and can give their consent to participate.

Inclusion Criteria

I am having vitrectomy eye surgery.
* able to give informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atropine eyedrops or no intervention following eye surgery

4 weeks
Weekly post-operative visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, visual recovery, and inflammation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Atropine

Trial Overview

The study is testing if using atropine 1% eyedrops after certain eye surgeries helps reduce pain and prevent the formation of scar tissue in the eye.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ExperimentalExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

The Effectiveness and Tolerability of Atropine Eye Drops for ...

The results of this review suggest that 0.01% atropine eye drops are effective in non-Asian regions achieving less side effects compared to 0.5% concentration.

Efficacy and Safety of Different Atropine Regimens for the ...

The group receiving nightly 0.05% atropine eye drops exhibited less 12-month axial eye growth than participants switched from nightly 0.01% ...

The CHAMP study: safety and efficacy of low-dose atropine

The CHAMP study results showed low-dose atropine is safe and effective in slowing myopia progression in children over 3yr period.

Efficacy and Safety of 8 Atropine Concentrations for Myopia ...

Atropine is known to be an effective intervention to delay myopia progression. Nonetheless, no well-supported evidence exists yet to rank the clinical outcomes ...

Exploring the STAR Study: Effective Myopia Management ...

Sit down with Rishi P. Singh, MD and Aaron M. Miller, MD, to review findings from the STAR study on low-dose atropine for myopia control.

Atropine Sulfate Ophthalmic Solution, 1% - accessdata.fda.gov

The safety and effectiveness of Atropine Sulfate Ophthalmic Solution 1% have been established in pediatric patients aged 3 months and older. Use of Atropine ...

SAFETY DATA SHEET Atropine Sulfate Ophthalmic ...

Protection of First-Aiders: Use personal protective equipment (see section 8). Signs and Symptoms: Eye: May cause irritation and hypersensitivity. (anaphylactic) ...

Atropine sulfate (ophthalmic route) - Side effects & dosage

Atropine sulfate eye drops is used to dilate the pupil before eye exams. It is also used to treat an eye condition called amblyopia (lazy eyes) and other eye ...

Minims Atropine Eye Drops

4.4 Special Warnings and Precautions for Use. Identified precautions. Minims Atropine Eye Drops are for topical ophthalmic use only. The solution should not ...

australian product information – minims atropine sulphate ( ...

It may cause adverse effects, such as rapid pulse, fever, or dry skin, in breastfeeding infants of mothers using ophthalmic atropine. 4.7 EFFECTS ON ABILITY TO ...