Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

Corneal Edema Clinical Trial

Official title:

Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853696
• Other study ID #: 2013-0424
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2013
• Last updated: April 29, 2015
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Cornea Research Foundation of America
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Graft rejection has traditionally been one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used for an extended period after transplant surgery. The purpose of this study is to compare the efficacy and side effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea transplant) surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Male or female patient who had endothelial keratoplasty procedure within the past 1 to 7 weeks

• Patient is able and willing to administer eye drops

• Patient is able to comprehend and has signed the Informed Consent form.

• Patient is likely to complete the one-year course of the study

Exclusion Criteria:

• A history of a previous rejection episode in the study eye

• A patient exhibiting intraocular inflammation

• A patient with a known sensitivity to any of the ingredients in the study medications

• A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study

• A patient with abnormal eyelid function.

• A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis.

• Presence of any ocular disease that would interfere with the evaluation of the study treatment. However, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled.

• A patient with a history of non-compliance with using prescribed medication.

• A patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study.

• Patients who are pregnant or planning to become pregnant within the duration of the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Corneal Edema
• Fuchs' Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• loteprednol etabonate

• prednisolone acetate 1%

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Cornea Research Foundation of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure	Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading.	from 1 to 12 months after transplant	Yes
Secondary	Immunologic Graft Rejection Episode	Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination.	within first year after cornea transplantation	Yes