A Two Chemoprophylaxis Approaches After Phacoemulsification Surgery

NCT ID: NCT03634852

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2018-02-01

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.

Detailed Description

Study design and populations:

The current clinical trial included a total 1000 patients with visually significant cataract scheduled to have phacoemulsification surgery at an Eye specialty private hospital in Baghdad /Iraq during 18 months period from 1st of October 2016 to 1st of February 2018 by two surgeons.

The current two methods of prophylaxis of postoperative endophthalmitis and inflammation were discussed with the patients and informed consent was obtained about the treatment and the enrollment in the current study.

Two methods of prophylaxis of postoperative bacterial endophthalmitis and inflammation were planned to use. For 500 patients (group 1) topical moxifloxacin hydrochloride 0.5% (Vigamox,Alcon) and dexamethasone 0.1%(Maxidex, Alcon) eye drops prescribed four times a day for 1-month postoperatively ,while for the remaining 500 patients (group 2), intracameral (IC) diluted moxifloxacin 0.1% and subconjunctival triamcinolone acetonide 4 mg/0.4 cc is the combination that planned to used for prophylaxis.

Preoperative evaluations:

The two surgeons follow the same protocol for the preoperative evaluation including slit lamp, Goldmann applanation tonometry(AT900, Haag-Streit Diagnostics, Switzerland), dilated fundus examination and macular optical coherence tomography (OCT)(Optovue, RTVue-100, Fremont, CA).

Follow- up visits were on the first postoperative day, 1week, 1 month, and 3months postoperatively.

The mean age of patients in group 1 was 59.4 years ± 9.04, 300 were female and 200 were male, 160 with type 2 diabetes mellitus without retinopathy and the preoperative intraocular pressure (IOP) range were from 10 to 25 mmHg with mean 14.49 mmHg ± 3.11.

Group 2 patients had a mean age of 59.7 ±8.84, 320 were female and 180 were male, 140 with good controlled diabetes and preoperative IOP mean was 14.47 mmHg ±3.10 range was from 9.5-20.6 mmHg.

statistical analysis: Minitab 16 software used for data statistical analysis, data were expressed in mean ± standard deviation (SD), for each group the preoperative baseline versus the corresponding postoperative data were compared by paired-sample t-test, while for the comparison of the 2 independent groups we used two-sample t-test and the results considered statistically significant if P value < 0.05.

Conditions

Endophthalmitis Postoperative

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Topical

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

Group Type: ACTIVE_COMPARATOR

Moxifloxacin hydrochloride 0.5% eye drops

Intervention Type: DRUG

were prescribed four times a day for 1-month postoperatively

Dexamethasone 0.1% eye drops

Intervention Type: DRUG

were prescribed four times a day for 1-month postoperatively

Intracameral - Subconjunctival

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

Group Type: ACTIVE_COMPARATOR

Intracameral Moxifloxacin 0.1%

Intervention Type: 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.

Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml

Intervention Type: 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

Interventions

Moxifloxacin hydrochloride 0.5% eye drops

were prescribed four times a day for 1-month postoperatively

Intervention Type: DRUG

Dexamethasone 0.1% eye drops

were prescribed four times a day for 1-month postoperatively

Intervention Type: DRUG

Intracameral Moxifloxacin 0.1%

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.

Intervention Type: DRUG

Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml

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

Intervention Type: DRUG

Other Intervention Names

Vigamox eye drops; Maxidex eye drops; Auromox; Aurocort

Eligibility Criteria

Inclusion Criteria

1. no current or previous intraocular inflammation,

2. no history of glaucoma or topical corticosteroid responsiveness.

3. All the included patients had normal preoperative fundus examination and normal preoperative macular OCT.

Exclusion Criteria

1. 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,

2. any patient with a history of glaucoma or steroid responsiveness

3. any patient with significant maculopathy were excluded from the current comparison.

• Minimum Eligible Age: 38 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Kindy College of Medicine

OTHER

Sponsor Role: collaborator

Suzan A Rattan

OTHER

Sponsor Role: lead

Responsible Party

Suzan A Rattan

Assistant professor in ophthalmology

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2 Al-KindyCM

Identifier Type: -

Identifier Source: org_study_id