Effect of Intracameral Steroids During Phacoemulsification on the Cornea

NCT05271058 | Completed Phase 3 DMC

• 1 other identifier: FMBSUREC/30042019/Mohamed
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Edema

Outcome Measures

Primary Outcomes (3)

• Corneal edema

  Clinical grade of corneal edema on the first postoperative day

  First day postoperative

• Central corneal thickness (CCT)

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

  Three months

• Endothelial cell loss

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

  Three months

Secondary Outcomes (1)

• IOP

  Three months

Study Arms (3)

Control group 1

SHAM COMPARATOR

23 eyes that did not receive any intraoperative steroids

Other: Control group

Dexamethasone group 2

ACTIVE COMPARATOR

23 eyes that received intracameral dexamethasone

Drug: Dexamethasone group

Triamcinolone (TA) group 3

ACTIVE COMPARATOR

23 eyes that received intracameral triamcinolone (TA)

Drug: Triamcinolone (TA) group

Interventions

Control group OTHER

23 eyes that didn't receive any intraoperative steroids

Also known as: No intraoperative steroids

Control group 1

Dexamethasone group DRUG

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.

Also known as: Intracameral Dexamethasone

Dexamethasone group 2

Triamcinolone (TA) group DRUG

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.

Also known as: Intracameral triamcinolone (TA)

Triamcinolone (TA) group 3

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataract grades 2 to 5 nuclear cataract (LOCS III scale)
• uneventful phacoemulsification operation

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Beni-Suef University: collaborator

Study Sites (1)

Khaled G Abueleinen

Giza, Cairo Governorate, 12411, Egypt

Location

MeSH Terms

Conditions

Corneal Edema

Interventions

Control Groups; Triamcinolone; Population Groups

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Demography; Population Characteristics

Study Officials

• Khaled G Abueleinen, MD, PhD

  Ophthalmology department, Faculty of Medicine Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 8, 2022
• Study Start: June 16, 2019
• Primary Completion: June 16, 2020
• Study Completion: August 15, 2020
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

EG (1)