Antibiotic Resistance In Eye Surgeries (ARIES)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Gut Resistome; Ocular Surface Microbiome; Antibiotic Resistance

Treatments: Drug: Moxifloxacin (Topical)

Study type: Interventional

Funder types: Other

Identifiers

NCT04750655

IRB#20-30037

Details and patient eligibility

About

In this study, the investigators seek to determine the effect of antibiotic use post-surgery on antimicrobial resistance. The investigators will be studying adults (aged 18 or older) who will undergo eye surgery at University of California, San Francisco (UCSF). We seek to gain a better understanding of how antibiotic use during the perioperative period influences local and systemic antibiotic resistance at the individual level.

Full description

Antibiotic use has saved millions of lives globally. However, this comes at the cost of selecting for antibiotic-resistant organisms at the individual and the community level. It is estimated that every year, approximately 700,000 deaths are associated with drug resistance globally. This places a significant burden on the public health system and the judicious use of antibiotics is more important than ever before.

The proposed masked, randomized controlled trial evaluates the effects of topical antibiotic use on the selection of antibiotic resistance determinants at the local and systemic levels. The results will provide guidance for antibiotic usage in ophthalmology and may have the potential to inform public health policies.

Enrollment: 108 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Over 18 years of age
2. Undergoing cataract surgeries that would benefit from intracameral antibiotics
3. Able to provide swabs
4. Able to provide consent
5. Surgery of the second eye occurs at least 8 weeks after surgery of the first eye

Exclusion criteria

1. Same-day bilateral cataract surgeries
2. On immunosuppression medication such as Prednisone, Methotrexate, Cellcept, or anti-TNF inhibitors within past 3 months
3. On systemic antibiotic within past 3 months
4. On topical antibiotics within past 8 weeks
5. Allergies to fluoroquinolone
6. Patients needing glaucoma drainage device or trabeculectomy
7. Inability to consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 3 patient groups, including a placebo group

Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics

Placebo Comparator group

Description:

intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops

Treatment:

Drug: Moxifloxacin (Topical)

Intraoperative antibiotics (Abx); Postoperative topical antibiotics four times a day for 1 week

Active Comparator group

Description:

intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week

Treatment:

Drug: Moxifloxacin (Topical)

Intraoperative antibiotics (Abx); Postoperative topical antibiotics once a day for 1 week

Active Comparator group

Description:

intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week

Treatment:

Drug: Moxifloxacin (Topical)