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NCT Number: NCT05271058

Effect of Intracameral Steroids During Phacoemulsification on the Cornea

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.

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Key information

Conditions

Corneal Edema Corneal Diseases Eye Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Khaled G Abueleinen

Giza, Cairo Governorate, 12411, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Group

Other

23 eyes that didn't receive any intraoperative steroids

Other names: No intraoperative steroids

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.

Other names: Intracameral Dexamethasone

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.

Other names: Intracameral triamcinolone (TA)

Primary outcomes

  1. Corneal edema

    Time frame: First day postoperative

    Clinical grade of corneal edema on the first postoperative day

  2. Central corneal thickness (CCT)

    Time frame: Three months

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

  3. Endothelial cell loss

    Time frame: Three months

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

Secondary outcomes

  1. IOP

    Time frame: Three months

    Intraocular pressure in mmHg rise after after phacoemulsification

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Beni-Suef University

Registry information

Official study title

Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2022
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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