Antibiotic Resistance In Eye Surgeries

NCT ID: NCT04750655

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-08-31

Brief Summary

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.

Detailed 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.

Conditions

Antibiotic Resistance; Ocular Surface Microbiome; Gut Resistome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics

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

Group Type: PLACEBO_COMPARATOR

Moxifloxacin (Topical)

Intervention Type: DRUG

We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.

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

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

Group Type: ACTIVE_COMPARATOR

Moxifloxacin (Topical)

Intervention Type: DRUG

We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.

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

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

Group Type: ACTIVE_COMPARATOR

Moxifloxacin (Topical)

Intervention Type: DRUG

We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.

Interventions

Moxifloxacin (Topical)

We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Han, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Thuy Doan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

Gaynor BD, Chidambaram JD, Cevallos V, Miao Y, Miller K, Jha HC, Bhatta RC, Chaudhary JS, Osaki Holm S, Whitcher JP, Holbrook KA, Fry AM, Lietman TM. Topical ocular antibiotics induce bacterial resistance at extraocular sites. Br J Ophthalmol. 2005 Sep;89(9):1097-9. doi: 10.1136/bjo.2005.068981.

Reference Type: BACKGROUND

PMID: 16113356 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IRB#20-30037

Identifier Type: -

Identifier Source: org_study_id