Intravitreal Triamcinolone and Moxifloxacin Injection After Cataract Surgery

NCT ID: NCT05428683

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-03
• Study Completion Date: 2021-12-10

Brief Summary

This study aims to evaluate the short-term effects and safety of prophylactic intra-vitreal injection of triamcinolone-moxifloxacin combination after cataract surgery. 84 patients underwent cataract surgery associated with intra-vitreal injection of triamcinolone-moxifloxacin combination after surgery.

Detailed Description

All the patients underwent the surgical removal of cataract by the same surgeon according to the standard protocols for modern phacoemulsification. Surgery was done under local anesthesia by peri-bulbar injection of local anesthetic. All operations were performed in an operating room by using an operating microscope under complete aseptic condition by using 10% povidone iodine solution applied to the skin of eye lid, eye lashes, side of the nose, eye brow and the skin of forehead. Before the operation, sterile drape and eyelid speculum were used, then 5% povidone iodine solution was applied to the bulbar conjunctiva and fornices for about 5 minutes, then was irrigated by balanced salt solution (BSS).

All the patients were followed up at the 1st day, 1st week, 1st month and at the 3rd month after the operation. At each visit the followings should be assessed: the post-operative refraction, the best corrected visual acuity and anterior and posterior segments examination for any sign of postoperative inflammation as cells and flare. Intra-ocular pressure (IOP) assessment and optical coherence tomography (OCT) images were also taken at the 1st and the 3rd postoperative months to assess the central macular thickness in suspected cases of cystoid macular edema (CME) based upon symptoms or signs observed on fundus examination, were confirmed by OCT of the macula through subjective interpretation via presence of cysts or an objective measurement of retinal thickness > 250 microns.

Conditions

Pharmacological Action

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prophylactic measures against post-operative inflammations

Usage of triamcinolone and moxifloxacin combination to be injected intravitreally by using 30 G needle.

Group Type: OTHER

intra-vitreal triamcinolone-moxifloxacin injection after cataract surgery as a prophylactic measures against post-operative endophthalmitis

Intervention Type: DRUG

At the end of surgery, 4mg triamcinolone acetonide and 0.2mg moxifloxacin from 0.5 moxifloxacin preservative-free eye drop) were injected once inferotemporally 3.5 mm posterior to the limbus via pars plana into the vitreous cavity by using 30 G needle.

Interventions

intra-vitreal triamcinolone-moxifloxacin injection after cataract surgery as a prophylactic measures against post-operative endophthalmitis

At the end of surgery, 4mg triamcinolone acetonide and 0.2mg moxifloxacin from 0.5 moxifloxacin preservative-free eye drop) were injected once inferotemporally 3.5 mm posterior to the limbus via pars plana into the vitreous cavity by using 30 G needle.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A significant cataract.
• Good control of diabetes mellitus (DM) and hypertension (HPT) if present.
• Visual acuity not less than hand movement (HM).

Exclusion Criteria

• The use of systemic or topical steroids, topical ophthalmic antibiotics, or non-steroidal anti-inflammatory drugs (NSAIDs) for one week before operation.
• Make an additional procedure at the same time with cataract surgery.
• Those with uncontrolled glaucoma or with marked visual field defect .
• Those with a significant macular edema due to DM, HPT, retinal vein occlusion (CRVO) or due to any previous inflammatory condition.
• Those with blepharitis or any other local disease interfering with surgical intervention or affecting on the surgical outcome.
• Occurrence of intraoperative complications as posterior capsular rupture or postoperative complications as retained lens fragment.

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emad Abdel Aal Saliem

OTHER

Sponsor Role: lead

Responsible Party

Emad Abdel Aal Saliem

Assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Emad A Saliem

Role: STUDY_DIRECTOR

Assistant Prof of ophthalmology, Al Azhar university

Locations

Emad AbdelAal Saliem

Ţahţā, Sohag Governorate, Egypt

Countries

Egypt

Other Identifiers

1221975

Identifier Type: -

Identifier Source: org_study_id