Effect of Intracameral Steroids During Phacoemulsification on the Cornea

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05271058
Collaborator
Beni-Suef University (Other)
69
1
3
14
4.9

Study Details

Study Description

Brief Summary

Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.

Intracameral steroids at the conclusion of phacoemulsification significantly improved corneal edema and spared corneal endothelium.

Condition or Disease Intervention/Treatment Phase
  • Other: Control group
  • Drug: Dexamethasone group
  • Drug: Triamcinolone (TA) group
Phase 3

Detailed Description

Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count.

Methods: Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.

On the first postoperative day corneal edema in control compared to dexamethasone and TA groups respectively.

One month later, the mean increase of corneal thickness in control compared to intracameral dexamethasone and TA groups, respectively.

mean endothelial cell loss in control compared to intracameral dexamethasone and TA groups respectively.

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count. Methods: Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count. Methods: Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium
Actual Study Start Date :
Jun 16, 2019
Actual Primary Completion Date :
Jun 16, 2020
Actual Study Completion Date :
Aug 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Control group 1

23 eyes that did not receive any intraoperative steroids

Other: Control group
23 eyes that didn't receive any intraoperative steroids
Other Names:
  • No intraoperative steroids
  • Active Comparator: Dexamethasone group 2

    23 eyes that received intracameral dexamethasone

    Drug: Dexamethasone group
    23 eyes each received intracameral dexamethasone at the conclusion of phacoemulsification Received intracameral 0.4 mg in / 0.1 ml dexamethasone (8mg/2ml®; Amriya or Epico) at the end of phacoemulsification.
    Other Names:
  • Intracameral Dexamethasone
  • Active Comparator: Triamcinolone (TA) group 3

    23 eyes that received intracameral triamcinolone (TA)

    Drug: Triamcinolone (TA) group
    23 eyes each received intracameral triamcinolone (TA) at the conclusion of phacoemulsification Received intracameral 2 mg/0.05 ml triamcinolone (TA) (Kenacort-A®; Bristol-Myers Squibb) at the end of phacoemulsification.
    Other Names:
  • Intracameral triamcinolone (TA)
  • Outcome Measures

    Primary Outcome Measures

    1. Corneal edema [First day postoperative]

      Clinical grade of corneal edema on the first postoperative day

    2. Central corneal thickness (CCT) [Three months]

      Central corneal thickness in microns after phacoemulsification that was compared to preoperative values

    3. Endothelial cell loss [Three months]

      Corneal endothelial cell count (cell/ square mm) after phacoemulsification that was compared to preoperative values

    Secondary Outcome Measures

    1. IOP [Three months]

      Intraocular pressure in mmHg rise after after phacoemulsification

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Cataract grades 2 to 5 nuclear cataract (LOCS III scale)

    • uneventful phacoemulsification operation

    Exclusion Criteria:
    • extremely hard cataract grade 6 nuclear cataract (LOCS III scale)

    • soft cataract

    • subluxated lenses or zonular dehiscence

    • associated ocular pathology such as glaucoma

    • any signs of uveitis

    • trauma

    • retinal detachment

    • vitrectomized or silicone filled eyes

    • corneal disease such as Fuch's dystrophy, corneal opacity

    • previous refractive corneal surgery

    • Cases that developed ruptured posterior capsule and vitreous loss

    • those lost to follow up were excluded and randomly replaced by the next chronological patient

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Khaled G Abueleinen Giza Cairo Egypt 12411

    Sponsors and Collaborators

    • Cairo University
    • Beni-Suef University

    Investigators

    • Principal Investigator: Khaled G Abueleinen, MD, PhD, Ophthalmology department, Faculty of Medicine Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    khaled gamal abueleinen, professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05271058
    Other Study ID Numbers:
    • FMBSUREC/30042019/Mohamed
    First Posted:
    Mar 8, 2022
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 8, 2022