A Two Chemoprophylaxis Approaches After Phacoemulsification Surgery

NCT03634852 | Completed Phase 4

• 1 other identifier: 2 Al-KindyCM
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post cataract surgery bacterial endophthalmitis is a rare but the most devastating complication with a poor visual outcome. The preferred pattern of chemoprophylaxis varied world widely. The use of preoperative povidone iodine is universal. Most European surgeons prefer the use of Intracameral (IC) antibiotics whereas topical fluoroquinolone that prescribed perioperatively is the most common pattern in the United state(US). The current study aimed to evaluate the effectivity and safety of a combination of diluted IC Moxifloxacin and subconjunctival (SC) Triamcinolone acetonide as prophylaxis of bacterial endophthalmitis and postoperative inflammation in five hundred phacoemulsification surgeries and compare its results with the same number of patients treated by topical Moxifloxacin hydrochloride and Dexamethasone eye drops when given four times a day for 1month postoperatively.

Conditions

Endophthalmitis Postoperative

Keywords

IC Moxifloxacin hydrochloride; SC triamcinolone acetonide

Outcome Measures

Primary Outcomes (1)

• Incidence of Bacterial endophthalmitis in 1000 phacoemulsification surgeries

  All patients assessed by slit lamp examination for possibility of early or late onset bacterial endophthalmitis after phacoemulsification surgery.

  The duration of follow up for each patient was a 3 months postoperatively.

Secondary Outcomes (1)

• Intraocular pressure(IOP) was measured on 1week,1month,and 3 months visits by Goldmann applanation tonometry .

  The duration of follow up for each patient was a 3 months postoperatively.

Other Outcomes (2)

• Break through inflammation (A significant anterior chamber reaction that may notice after 10 days postoperatively).

  The duration of follow up for each patient was a 3 months postoperatively.

• Central macular thickness (CMT)

  OCT was done preoperatively and 3 months postoperatively.

Study Arms (2)

Topical

ACTIVE COMPARATOR

Moxifloxacin hydrochloride 0.5% eye drops and dexamethasone 0.1% eye drops were prescribed four times a day for 1 month postoperatively.

Drug: Moxifloxacin hydrochloride 0.5% eye drops; Drug: Dexamethasone 0.1% eye drops

Intracameral - Subconjunctival

ACTIVE COMPARATOR

Intracameral Moxifloxacin 0.1% with Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml had been administered at the conclusion of the surgery

Drug: Intracameral Moxifloxacin 0.1%; Drug: Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml

Interventions

Moxifloxacin hydrochloride 0.5% eye drops DRUG

were prescribed four times a day for 1-month postoperatively

Also known as: Vigamox eye drops

Topical

Dexamethasone 0.1% eye drops DRUG

were prescribed four times a day for 1-month postoperatively

Also known as: Maxidex eye drops

Topical

Intracameral Moxifloxacin 0.1% DRUG

Auromox (0.5%): is a sterile clear yellow pale colored preservative free isotonic ophthalmic solution with pH 6.0 to 7.5 and osmolarity 620 -320 milliosmol ( mOsm).The sterile Auromox vial contains 1cc Moxifloxacin hydrochloride 5.45 mg equivalent to 5mg of Moxifloxacin. This product is manufactured by Aurolab an Indian pharmaceutical company. Auromox is available in many countries including Iraq. Each vial enough for 15 different patients by using a sterile needle and 5cc syringe. By the sterile hand's, the surgeon draws the whole 1cc of Moxifloxacin 0.5% and diluted with 4 cc of balanced salt solution (BSS) to get 5 mg in 5 cc (0.1%) then draw 0.2 cc for each patient.

Also known as: Auromox

Intracameral - Subconjunctival

Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml DRUG

Aurocort is a preservative-free Triamcinolone acetonide (40 mg /1cc), with along acting depot preparation of triamcinolone in 1cc vial also the product of Aurolab company and commercially available in our country. The whole 1cc had been drawn and diluted with 3cc of BSS and SC injection of 4 mg in 0.4 cc of Triamcinolone was given (as a final step in the surgery) 6mm from the limbus usually an inferotemporal site that is easily accessible and the plaque that formed will be not visible within palpebral fissure

Also known as: Aurocort

Intracameral - Subconjunctival

Eligibility Criteria

• Age: 38 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• no current or previous intraocular inflammation,
• no history of glaucoma or topical corticosteroid responsiveness.
• All the included patients had normal preoperative fundus examination and normal preoperative macular OCT.

You may not qualify if:

• For group 2; any patient used a topical antibiotic, nonsteroidal anti-inflammatory drug (NSAID) or corticosteroid up to 1 week before the planned day of surgery,
• any patient with a history of glaucoma or steroid responsiveness
• any patient with significant maculopathy were excluded from the current comparison.

Sponsors & Collaborators

• Suzan A Rattan: lead
• Al-Kindy College of Medicine: collaborator

MeSH Terms

Interventions

Moxifloxacin; Ophthalmic Solutions; Dexamethasone

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor in ophthalmology

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 17, 2018
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: May 3, 2023

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share