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Intravitreal Triamcinolone and Moxifloxacin Injection After Cataract Surgery

Assistant Professor, Ophthalmology Department, Al Azhar University

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05428683
Enrollment
84
Registered
2022-06-23
Start date
2020-12-03
Completion date
2021-12-10
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacological Action

Keywords

Endophthalmitis

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.

Interventions

DRUGintra-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.

Sponsors

Emad Abdel Aal Saliem
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

cataract surgery followed by intravitreal injection of triamcinolone and moxifloxacin combination as a prophylaxis against endophthalmitis

Eligibility

Sex/Gender
ALL
Age
48 Years to 66 Years
Healthy volunteers
No

Inclusion criteria

Patients underwent uncomplicated cataract surgery with: * 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 followings were the

Design outcomes

Primary

MeasureTime frameDescription
Post operative best corrected visual acuityat the end of 3rd month.describe the differences between pre & post operative best corrected visual acuity by snellen's chart. The mean BCVA showed a statistically significant differences between the preoperative and the postoperative values, where the main BCVA improved from 1.21±0.27 logMAR before operation (at baseline) to 0.19±0.14 logMAR at the 3rd month. For statistical analysis, the best- corrected visual acuity data were transformed to LogMAR. Investigators calculated the mean, standard deviation, range, confidence interval, and Pearson correlation.
A condition of the eye after cataract surgery without use of topical medications.purpose of this study is to evaluate the efficacy of these used drugs after surgery not before it during follow up period at the end of 3rd month.By SLITLAMP examination, investigators search for signs of postoperative endophthalmitis or inflammations as cells or flare that required supplemental anti-inflammatory medications. So, evaluate the use of triamcinolone-moxifloxacin combination after cataract surgery when injected intra-vitreally against postoperative endophthalmitis and/or other intraocular inflammations without use of topical anti-infective and/or anti-inflammatory medications whether before or even after cataract surgery.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026