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Comparison of two antibiotics in cataract surgery prophylaxis.

Not yet recruiting
Conditions
Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified,
Registration Number
CTRI/2023/04/051491
Lead Sponsor
JIPMER
Brief Summary

Patients will be randomized to either group A or group B by sealed envelope technique. A sterile conjunctival swab moistened in sterile saline will be used to take a conjunctival swab for all patients. All swabs will be rotated three times completely with slight pressure in the inferior conjunctival fornix without contacting the eyelids and eyelashes. They will be collected without instilling topical anaesthetic drops. The first culture will be obtained before instilling the antibiotic drops (T0). Group A patients will receive 0.3% ciprofloxacin eyedrops and group B patients will receive 0.5% moxifloxacin eye drops. Both the groups will receive antibiotic drops at 2pm, 6pm, 10pm and 8 am. An hour following the last antibiotic drop, a second conjunctival culture will be taken (T1). Participants in the study will be followed up at 1 week and 4 weeks postop for signs of infection (Best corrected visual acuity measured in feet by Snellen’s chart , lid edema, chemosis, hypopyon and vitritis)

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
168
Inclusion Criteria

All patients above 40 years of age who are enrolled for cataract surgery will be included in the study.

Exclusion Criteria
  • Ocular or systemic infection; 2.
  • presence of ec-tropion, entropion, trichiasis or distichiasis; 3.
  • usage of systemic or topical antibiotics or steroids within 30 days of enrolling in the study; 4.
  • primary or sec-ondary immunocompromised patients; 5.
  • debilitated patients; 6.
  • chronic renal failure patients on dialysis; 7.
  • inability to comprehend or unwilling to provide informed consent.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To determine the effect of preoperative Ciprofloxacin compared to Moxifloxacin by assessing the difference in the proportion of eyes with negative bacterial cul-tureThe first culture will be obtained before instilling the antibiotic drops (T0).Both the groups will receive antibiotic drops at 2pm, 6pm, 10pm and 8 am. An hour following the last antibiotic drop, a second conjunctival culture will be taken (T1).
Secondary Outcome Measures
NameTimeMethod
To determine the efficacy of ciprofloxacin and moxi-floxacin on the bacterial isolates from conjunctival cultures.To determine the clinical signs of infection in both group of patients postoperatively at one week and four weeks

Trial Locations

Locations (1)

JIPMER KARAIKAL

🇮🇳

Karaikal, PONDICHERRY, India

JIPMER KARAIKAL
🇮🇳Karaikal, PONDICHERRY, India
DR NIRUBAN G
Principal investigator
04368228075
niruban@jipmer.ac.in

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