A study to understand the safety and effect of different dosage of antibiotic injected into the eye during the time of cataract surgery

Not Applicable

Completed

• Conditions: Health Condition 1: null- Ophthalmology - Cataract SurgeryHealth Condition 2: H598- Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified

• Registration Number: CTRI/2017/12/010759
• Lead Sponsor: Aravind Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-11-10
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Subjects MUST:

1.Provide signed and dated written informed consent.

2.Be 45 - 85 years of age

3.Have bilateral cataracts with similar nuclear density in each eye, and which is less than NO4/NC4 on the Lens Opacities Classification System III (LOCSIII) eligible for cataract extraction.

4.Be suitable for the surgeonââ?¬•s standard phacoemulsification technique.

5.Be able and willing to follow study instructions and complete all required visits

6.At Eligibility (Visit 2/Day -7), have ECD of >2000 cells/mm2 in both eyes with difference between eyes being <200 cells as assessed by a centralized reading center.

Exclusion Criteria

Subjects MUST NOT:

1.Have any ocular disease other than cataract (uncontrolled glaucoma, blunt or penetrating ocular trauma, uveitis, endothelial corneal dystrophy)

2.Have pseudoexfoliation, or small pupils that would require expansion devices

3.Taking immunosupressants, systemic alpha blockers, or anticoagulants

4.Have bilateral nuclear density NO4/NC4 on the Lens Opacities Classification System III (LOCSIII) or greater.

5.Previous angle closure glaucoma or shallow anterior chambers.

6.Previous hard (PMMA) contact lens wear.

7.Have uncontrolled systemic disease (e.g. diabetes)

8.Current or history of severe hepatic or renal impairment. Have severe cardiovascular disease unless his/her disease is controlled and clearance has been obtained from the treating primary care physician or cardiologist

9.If female of childbearing potential - Be pregnant, nursing, or planning a pregnancy during study entry and through the duration of the study.

10. Have clinically relevant, abnormally low or high blood pressure or pulse rate (normal ranges: systolic: 90-160 mm Hg; diastolic: 55-90 mm Hg; pulse rate: 50-100 bpm)

11.Use of intracameral pilocarpine or adrenaline during the surgery

12.Have any known allergy or sensitivity to the study medications or their components (moxifloxacin).

13.Require the use of any ocular medications during the study other than the study medications; occasional use of artificial tears for mild dry eye or lid scrubs for mild blepharitis is allowed. [Note: If subject uses artificial tears or lib scrubs, the treatment must be administered at least 30 minutes prior to study medication instillation].

14.Have any contraindications to moxifloxacin

15.Have any active ocular disease other than glaucoma that requires treatment or may affect the safety or efficacy of the study medication, in the opinion of the investigator. Please note, artificial tears for mild dry eye and lid scrubs for mild blepharitis are allowed.

16.Have any opacity or subject uncooperativeness that restricts adequate examination of the anterior chamber

17.Current or history within 2 months prior to eligibility visit infectious/non-infectious ocular disease or condition conjunctivitis, keratitis, or uveitis in any eye. However, subjects with cataract, age-related macular degeneration or diabetic retinopathy can be enrolled as per discretion of investigator.

18.Have refractivesurgery,lasertrabeculoplasty,orotherlasersurgerywithinthepast 3months,orotherocular surgery (e.g. filtering surgery)withinthepast12months

19.Be enrolled in an investigational drug or device study or have participated in such a study within 30 days prior to eligibility visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demonstrate non-inferiority in central endothelial cell loss between eyes receiving 500 mcg/0.1 ml v/s 250 mcg/0.1ml intracameral moxifloxacin following phacoemulsificationTimepoint: 3 months

Secondary Outcome Measures

Name	Time	Method
Visual Acuity <br/ ><br>TASS (Toxic Anterior Segment Syndrome) <br/ ><br>EndophthalmitisTimepoint: 3 months