Antibiotic Resistance In Eye Surgeries

Phase 4

Completed

Conditions: Ocular Surface Microbiome
Antibiotic Resistance
Gut Resistome

Interventions: Drug: Moxifloxacin (Topical)

Registration Number: NCT04750655

Lead Sponsor: University of California, San Francisco

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 108

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraoperative antibiotics (Abx); Postoperative topical antibiotics once a day for 1 week	Moxifloxacin (Topical)	intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week
Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics	Moxifloxacin (Topical)	intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops
Intraoperative antibiotics (Abx); Postoperative topical antibiotics four times a day for 1 week	Moxifloxacin (Topical)	intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week

Primary Outcome Measures

Name	Time	Method
Antimicrobial Resistance (AMR) of Conjunctiva at 1 Week	1 Week	Normalized read counts (reads per million reads or rM) for fluoroquinolone resistance determinants from DNA deep sequencing for the conjunctival swabs at 1 week, which represent the abundance of resistance in the sample.

Secondary Outcome Measures

Name	Time	Method
Antimicrobial Resistance (AMR) of Nasopharynx at 1 Week	1 week	Normalized read counts (reads per million reads or rM) for fluoroquinolone resistance determinants from DNA deep sequencing for the nasopharyngeal swabs at 1 week, which represent the abundance of resistance in the sample.
Shannon's Index	1 week	Conjunctival samples were evaluated for microbiome heterogeneity at 1 week. Shannon's index (H) represents a measure of bacteria species heterogeneity and is calculated through the following formula, H = -sum(pi\log(b)\pi), where pi is the proportional abundance of species and b is the base of the logarithm. Here, we are using the natural logarithm. The Shannon's Index ranges from 0 to ln(S), where S is the number of species in the community. We report the exponentiated Shannon's Index, which is expressed as the "effective number of species", which ranges from 1 to S species. An effective number of species of 1 indicates that 1 species dominates the microbiome. The greater the effective number of species, the greater the heterogeneity of species abundance in the microbiome. Low heterogeneity of bacterial species in the microbiome is a proxy for a less healthy system.
Simpson's Index	1 week	Nasopharyngeal samples were evaluated for microbiome heterogeneity at 1 week. Simpson's index (D) represents a measure of bacteria species heterogeneity and is calculated through the following formula, D = sum(pi\^2), where pi is the proportional abundance of species. The Simpson's Index ranges from 0 to 1, where 0 represents infinite heterogeneity and 1 represents no heterogeneity. We report the inverse of Simpson's Index, which is expressed as the "effective number of species", which ranges from 1 to S species. An effective number of species of 1 indicates that 1 species dominates the microbiome. The greater the effective number of species, the greater the heterogeneity of species abundance in the microbiome. Low heterogeneity of bacterial species in the microbiome is a proxy for a less healthy system.