Effect of Intracameral Dexamethasone After Phacoemulsification in Diabetics on Corneal Endothelial Cell Density

NCT03361709 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: CU201712
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The prevalence of diabetes mellitus (DM) is rapidly growing worldwide. One major concern with diabetes mellitus is how it may affect vision in different ways; including the increased risk of developing cataract. Several studies have found an association between diabetes mellitus and the development of cataract. In patients with DM, cataract progression is also faster and occurs at a younger age.5 While results for modern cataract surgery are satisfactory, cataract surgery in diabetic patients carries a higher risk of peri and post-operative complications than in non-diabetic patients. Several studies have shown that the corneal endothelial count of diabetic patients is decreased, with more damage occurring to corneal endothelial cells following phacoemulsification in diabetics than in non-diabetics. This is presumed to be due to increased vulnerability of corneal endothelial cells in diabetics and a delay in the repair process. Administration of topical corticosteroids is the main method to control post-operative inflammation after phacoemulsification, however many studies have also proved the safety and efficacy of intracameral corticosteroids to control inflammation post-operatively. While intracameral triamcinolone is effective in controlling post-operative inflammation, elevation of intraocular pressure is a main concern. Dexamethasone has been found to be effective in controlling post-operative inflammation with no effect on intraocular pressure. This may be due to its rapid turnover and short half-life. No studies however have been performed to evaluate the safety and benefit of intracameral injection of dexamethasone following phacoemulsification in diabetic patients. In the present study, investigators aim to evaluate this and determine its effect on the post-operative corneal endothelial cell density and corneal thickness.

Conditions

Diabetes Mellitus; Corneal Endothelial Cell Loss; Dexamethasone Adverse Reaction; Corneal Endothelial Decompensation

Outcome Measures

Primary Outcomes (1)

• Mean change in corneal endothelial cell density before and after phacoemulsification

  This will be assessed using specular microscopy

  1 month

Secondary Outcomes (3)

• Central corneal thickness

  1 month

• Intraocular inflammation

  1 month

• Intraocular pressure

  1 month

Study Arms (2)

Dexamethasone group

ACTIVE COMPARATOR

Dexamethasone injected at conclusion of Phacoemulsification

Drug: Dexamethasone

Non-dexamethasone group

PLACEBO COMPARATOR

No dexamethasone will be injected at the conclusion of Phacoemulsification

Drug: Saline Solutions, Intraocular

Interventions

Dexamethasone DRUG

Dexamethasone will be injected intracamerally at the conclusion of Phacoemulsification

Also known as: Decadron

Dexamethasone group

Saline Solutions, Intraocular DRUG

Only saline will be injected intracamerally at conclusion of Phacoemulsification

Non-dexamethasone group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years old
• Type 1 or Type 2 diabetes duration ≥ 10 years
• Visually significant cataract

You may not qualify if:

• Dense central corneal opacities as dense nebulae and stromal dystrophies.
• Pre-operative endothelial cell count less than 1500 cell/mm2
• Fuchs dystrophy
• Associated ocular conditions that could affect endothelial cell count as glaucoma and uveitis
• Previous intraocular surgeries

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Diabetes Mellitus; Corneal Endothelial Cell Loss

Interventions

Dexamethasone; Calcium Dobesilate; Sodium Chloride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Corneal Diseases; Eye Diseases; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ahmed A. Dahab, MD

  Cairo University

  STUDY DIRECTOR

• Ahmed A Abdel Azim, MD

  Cairo University

  STUDY DIRECTOR

• Shaimaa A Arfeen, MD

  Cairo University

  STUDY DIRECTOR

• Ayman GA Elnahry, Msc

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Demonstrator

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: January 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share