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Low Dose Atropine for Symptomatic Vitreous Floaters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06174935
Recruitment Status : Not yet recruiting
First Posted : December 18, 2023
Last Update Posted : December 18, 2023
Sponsor:
Information provided by (Responsible Party):
Jeanette Du, Prism Vision Group

Study Description
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Brief Summary:
The objective of this study is to identify a potential pharmacologic option by assessing whether 0.01% atropine may be effective for treating bothersome floaters as measured by scores on a modified NEI VFQ-25.

Condition or disease Intervention/treatment Phase
Vitreous Floaters Drug: 0.01% atropine ophthalmic drop Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Dose Atropine For Symptomatic Vitreous Floaters
Estimated Study Start Date : January 1, 2024
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Atropine 0.01%
Patients will apply 1 drop daily of atropine 0.01%
 Drug: 0.01% atropine ophthalmic drop
0.01% atropine ophthalmic drop will be applied daily to the affected eye


Outcome Measures
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Primary Outcome Measures :
  1. Symptom improvement assessed by questionnaire [ Time Frame: Up to 2 months ]
    NEI VFQ-25 = National Eye Institute Visual Function Questionnaire


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients within Prism Vision Group with ICD diagnosis of acute posterior vitreous detachment and none of the ocular comorbidities listed as exclusion criteria will be screened as potential study participants.

Exclusion Criteria:

  • Patients with vitreous hemorrhage, other significant media opacity or vitreoretinal pathology, or history of pars plana vitrectomy will be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06174935


Contacts
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Contact: Jeanette Du, MD 844-749-3627 JDu@rgw.com

Locations
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United States, Virginia
Retina Group of Washington
Reston, Virginia, United States, 20190
Contact: Jeanette Du, MD    844-749-3627    jdu@rgw.com   
Sub-Investigator: Jeanette Du, MD         
Principal Investigator: Mohsin Ali, MD         
Sponsors and Collaborators
Jeanette Du
More Information
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Responsible Party: Jeanette Du, Physician, Prism Vision Group
ClinicalTrials.gov Identifier: NCT06174935    
Other Study ID Numbers: 1362664
First Posted: December 18, 2023    Key Record Dates
Last Update Posted: December 18, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eye Diseases
Atropine
Ophthalmic Solutions
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
 Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions