APPRAISE: Assessment of Pain and Posterior Synechiae Reduction With Atropine, an Investigation of Post-Surgical Eyes

ConditionEye Disorders
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

The study will evaluate whether atropine eyedrops are beneficial when used after certain eye surgeries.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patient undergoing vitrectomy surgery

able to give informed consent

Disqualifiers

post-operative eyedrop regimens that include topical non steroidal anti-inflammatory medications

subjects with altered post-operative eyedrop schedule for enhanced inflammation control

documented allergy to atropine

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atropine 1%

    Drug

    Subtraction of atropine eyedrops from post-operative treatment regimen

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain score on the Visual Analog Scale (VAS)

Whether atropine use impacts post-operative pain score on the standard Visual Analog Scale (VAS)

Time frame
1 month

Secondary outcomes

1

Anterior chamber inflammation (aqueous cell and flare)

Whether atropine impacts the occurrence of post-operative inflammation, quantified as aqueous cell and flare, using the Standardization of Uveitis Nomenclature (SUN) Criteria

Time frame
1 month
2

Cystoid macular edema detected by optical coherence tomography

Whether atropine impacts the occurrence of cystoid macular edema after surgery, detected by optical coherence tomography scanning of the retina

Time frame
1 month
3

Time to visual recovery

Whether atropine impacts the time to visual recovery

Time frame
1 month
4

Intraocular pressure

Whether atropine impacts intraocular pressure after surgery

Time frame
1 month

Other outcomes

Sponsors and contacts

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