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Effect of Intracameral Steroids During Phacoemulsification on the Cornea

Primary Purpose

Corneal Edema

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Control group
Dexamethasone group
Triamcinolone (TA) group
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Corneal Edema

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Khaled G Abueleinen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Control group 1

Dexamethasone group 2

Triamcinolone (TA) group 3

Arm Description

23 eyes that did not receive any intraoperative steroids

23 eyes that received intracameral dexamethasone

23 eyes that received intracameral triamcinolone (TA)

Outcomes

Primary Outcome Measures

Corneal edema
Clinical grade of corneal edema on the first postoperative day
Central corneal thickness (CCT)
Central corneal thickness in microns after phacoemulsification that was compared to preoperative values
Endothelial cell loss
Corneal endothelial cell count (cell/ square mm) after phacoemulsification that was compared to preoperative values

Secondary Outcome Measures

IOP
Intraocular pressure in mmHg rise after after phacoemulsification

Full Information

First Posted
February 16, 2022
Last Updated
February 27, 2022
Sponsor
Cairo University
Collaborators
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05271058
Brief Title
Effect of Intracameral Steroids During Phacoemulsification on the Cornea
Official Title
Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 16, 2019 (Actual)
Primary Completion Date
June 16, 2020 (Actual)
Study Completion Date
August 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Edema

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group 1
Arm Type
Sham Comparator
Arm Description
23 eyes that did not receive any intraoperative steroids
Arm Title
Dexamethasone group 2
Arm Type
Active Comparator
Arm Description
23 eyes that received intracameral dexamethasone
Arm Title
Triamcinolone (TA) group 3
Arm Type
Active Comparator
Arm Description
23 eyes that received intracameral triamcinolone (TA)
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
No intraoperative steroids
Intervention Description
23 eyes that didn't receive any intraoperative steroids
Intervention Type
Drug
Intervention Name(s)
Dexamethasone group
Other Intervention Name(s)
Intracameral Dexamethasone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone (TA) group
Other Intervention Name(s)
Intracameral triamcinolone (TA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Corneal edema
Description
Clinical grade of corneal edema on the first postoperative day
Time Frame
First day postoperative
Title
Central corneal thickness (CCT)
Description
Central corneal thickness in microns after phacoemulsification that was compared to preoperative values
Time Frame
Three months
Title
Endothelial cell loss
Description
Corneal endothelial cell count (cell/ square mm) after phacoemulsification that was compared to preoperative values
Time Frame
Three months
Secondary Outcome Measure Information:
Title
IOP
Description
Intraocular pressure in mmHg rise after after phacoemulsification
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled G Abueleinen, MD, PhD
Organizational Affiliation
Ophthalmology department, Faculty of Medicine Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khaled G Abueleinen
City
Giza
State/Province
Cairo
ZIP/Postal Code
12411
Country
Egypt

12. IPD Sharing Statement

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Effect of Intracameral Steroids During Phacoemulsification on the Cornea

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