Measuring Corneal Cells With Specular Microscopy

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

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

Study Overview

• Status: Completed
• Conditions: Retinal Diseases

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96815
      • Retina Institute of Hawaii

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects of either gender with an age greater than 50 years of age who have been receiving intraocular Anti-VEGF medication every month for at least the past 3 months.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Retina Institute of Hawaii

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: RIH 1011