Antibiotic Resistance In Eye Surgeries

Study Overview
=================
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.

Official Title
-----------------
Antibiotic Resistance In Eye Surgeries (ARIES)

Conditions
-----------------
Antibiotic Resistance, Ocular Surface Microbiome, Gut Resistome

Intervention / Treatment
-----------------
* Drug: Moxifloxacin (Topical)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics<br>intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops | Drug: Moxifloxacin (Topical)<br>* We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.<br>|
| Active Comparator: Intraoperative antibiotics (Abx); Postoperative topical antibiotics four times a day for 1 week<br>intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week | Drug: Moxifloxacin (Topical)<br>* We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.<br>|
| Active Comparator: Intraoperative antibiotics (Abx); Postoperative topical antibiotics once a day for 1 week<br>intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week | Drug: Moxifloxacin (Topical)<br>* We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial Resistance (AMR) of Conjunctiva at 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. | 1 Week | 
| Antimicrobial Resistance (AMR) of Nasopharynx at 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. | 1 week | 
| Antimicrobial Resistance (AMR) of Oral at 1 week | Normalized read counts (reads per million reads or rM) for fluoroquinolone resistance determinants for the buccal swabs at 1 week. | 1 week | 
| Antimicrobial Resistance (AMR) of Gut at 1 Week | Normalized reads counts (reads per million reads or rM) for fluoroquinolone resistance determinants for the rectal swabs at 1 week. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Microbiome with Shannon's diversity index at 1 week | Shannon's diversity index (H) will be measured to calculate species richness of ocular surface microbiome at 1 week. Shannon's diversity index (H) 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. | 1 week | 
| Ocular Surface Microbiome with Simpson's diversity index at 1 week | Simpson's diversity index (D) will be measured to calculate species richness of ocular surface microbiome at 1 week. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species. | 1 week | 
| Ocular Surface Microbiome with Shannon's diversity index at 1 month | Shannon's diversity index (H) will be measured to calculate species richness of ocular surface microbiome at 1 month. Shannon's diversity index (H) 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. | 1 month | 
| Ocular Surface Microbiome with Simpson's diversity index at 1 month | Simpson's diversity index (D) will be measured to calculate species richness of ocular surface microbiome at 1 month. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species. | 1 month | 
| Nasopharyngeal Microbiome with Shannon's diversity index at 1 week | Shannon's diversity index (H) will be measured to calculate species richness of nasopharyngeal microbiome at 1 week. Shannon's diversity index (H) 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. | 1 week | 
| Nasopharyngeal Microbiome with Simpson's diversity index at 1 week | Simpson's diversity index (D) will be measured to calculate species richness of nasopharyngeal microbiome at 1 week. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species. | 1 week | 
| Nasopharyngeal Microbiome with Shannon's diversity index at 1 month | Shannon's diversity index (H) will be measured to calculate species richness of nasopharyngeal microbiome at 1 month. Shannon's diversity index (H) 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. | 1 month | 
| Nasopharyngeal Microbiome with Simpson's diversity index at 1 month | Simpson's diversity index (D) will be measured to calculate species richness of nasopharyngeal microbiome at 1 month. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species. | 1 month | 
| Gut Microbiome with Shannon's diversity index at 1 week | Shannon's diversity index (H) will be measured to calculate species richness of gut microbiome at 1 week. Shannon's diversity index (H) 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. | 1 week | 
| Gut Microbiome with Simpson's diversity index at 1 week | Simpson's diversity index (D) will be measured to calculate species richness of gut microbiome at 1 week. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species. | 1 week | 
| Oral Microbiome with Shannon's diversity index at 1 Week | Shannon's diversity index (H) will be measured to calculate species richness of oral microbiome at 1 week. Shannon's diversity index (H) 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. | 1 week | 
| Oral Microbiome with Simpson's diversity index at 1 Week | Simpson's diversity index (D) will be measured to calculate species richness of oral microbiome at 1 week. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species. | 1 week | 
| Oral Microbiome with Shannon's diversity index at 1 Month | Shannon's diversity index (H) will be measured to calculate species richness of oral microbiome at 1 month. Shannon's diversity index (H) 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. | 1 month | 
| Oral Microbiome with Simpson's diversity index at 1 Month | Simpson's diversity index (D) will be measured to calculate species richness of oral microbiome at 1 month. Simpson's diversity index (D) is calculated through the following formula, D = sum(pi^2), where pi is the proportional abundance of species. | 1 month |