Antibiotic Resistance In Eye Surgeries (ARIES)

August 2, 2022 updated by: University of California, San Francisco

Antibiotic Resistance In Eye Surgeries (ARIES)

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics
intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops
We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.
Active Comparator: 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
We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.
Active Comparator: 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
We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antimicrobial Resistance (AMR) of Conjunctiva at 1 week
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ying Han, MD, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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