Endothelial Cell Loss, Corneal Clinical Trial
Official title:
Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule: a Prospective Randomised Double-masked Study
Verified date | February 2019 |
Source | Vienna Institute for Research in Ocular Surgery |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cataract surgery is one of the most frequently performed surgical procedures worldwide. Since
the introduction of phacoemulsification to remove the cataractous lens, risk and complication
rates of cataract surgery decreased significantly.
The phacoemulsification technique utilizes a high-intensity ultrasound energy for the
fragmentation and emulsification of the lens. One of the main complications during
phacoemulsification, is damaging of the endothelium due to contact with lens fragments of the
nucleus following turbulent flow of irrigating solution, resulting in corneal damage,
inflammation of the endothelium and corneal edema.
In this study we want to evaluate the effect of the anterior capsule, gained by capsular
rhexis, as a corneal shield during phacoemulsification on the corneal endothelium.
Status | Completed |
Enrollment | 70 |
Est. completion date | April 5, 2018 |
Est. primary completion date | April 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Cataract - Age 21 and older - Written informed consent prior to surgery - Moderate to severe nuclear or mixed cataract Exclusion Criteria: - Corneal pathologies - Pregnancy - Patients with an increased surgical risk (i.e. patients with pseudoexfoliation syndrome, patients with the potential risk of intra-operative floppy iris syndrome) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Prim. Prof. Dr. Oliver Findl, MBA |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | endothelium cell loss | Comparison of the lost endothelium cells in both groups | 1 year | |
Secondary | central corneal thickness | Comparison of corneal thickness between both groups | 1 year |
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