Intravitreal Triamcinolone and Moxifloxacin Injection After Cataract Surgery

NCT05428683 | Completed

• 1 other identifier: 1221975
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacological Action

Keywords

Endophthalmitis

Outcome Measures

Primary Outcomes (2)

• Post operative best corrected visual acuity

  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.

  at the end of 3rd month.

• A condition of the eye after cataract surgery without use of topical medications.

  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.

  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.

Study Arms (1)

prophylactic measures against post-operative inflammations

OTHER

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

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

Interventions

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

prophylactic measures against post-operative inflammations

Eligibility Criteria

• Age: 48 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emad Abdel Aal Saliem: lead

Study Sites (1)

Emad AbdelAal Saliem

Ţahţā, Sohag Governorate, Egypt

Location

MeSH Terms

Conditions

Endophthalmitis

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases

Study Officials

• Emad A Saliem

  Assistant Prof of ophthalmology, Al Azhar university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

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

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: June 23, 2022
• Study Start: December 3, 2020
• Primary Completion: August 17, 2021
• Study Completion: December 10, 2021
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

EG (1)