Measuring Corneal Cells With Specular Microscopy

Retinal Diseases Clinical Trial

Official title:

Specular Photomicrograpic Assessment of the Effect of Anti-VEGF Intravitreal Injections on Corneal Thickness and Endothelial Cell Density and Morphology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792154
• Other study ID #: RIH 1011
• Status: Completed
• Phase: N/A
• First received: February 11, 2013
• Last updated: February 12, 2013
• Start date: August 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: Retina Institute of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data Safety Board
• Study type: Observational

Clinical Trial Summary

Assess changes in the corneal cell count using Specular Microscopy following tretments with Anti-VEGF injections

Description:

Patients with active Wet AMD often receive intraocular Anti-VEGF injections such as Macugen, Lucentis and Avastin on a monthly basis for an extended period of time. While these medications are very effective at controlling the Choroidal Neovascularization associated with this disease, the impact of monthly intravigtreal Anti-VEGF injections on the viability of corneal endothelial cells has yet to be fully characterized. The availability of CESM as a diagnostic test that can be performed quickly and painlessly in the clinic offers a method of tracking corneal endothelial cell count in this patient population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Wet Age-related Macular Degeneration

• Receiving monthly intraocular injections of Anti-VEGF medication for at least 3 months

• Age greater than 50 years of age

Exclusion Criteria:

• experiences adverse events

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Retinal Diseases

Locations

Country	Name	City	State
United States	Retina Institute of Hawaii	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Retina Institute of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specular Photomicrographic Assessment of the Effect of Anti-VEGF Intravitreal injections on corneal thickness and endothelial cell density and morphology	Changes in corneal endothelial cell density and corneal thickness measured by changes in pachymetry and corneal cell count.	Baseline, Month 6 and Month 12	No