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NCT02698943 Clinical Trial

Glistenings and PCO Evaluation for the Envista MX60

Cataract Clinical Trial

Official title:
Evaluation of Glistenings and Posterior Capsule Opacification Following Envista MX60 Intraocular Lens Implantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02698943
Other study ID # 320/2-3-2016
Secondary ID
Status Completed
Phase N/A
First received March 2, 2016
Last updated March 2, 2016
Start date September 2015
Est. completion date February 2016

Study information
Verified date March 2016
Source Democritus University of Thrace
Contact n/a
Is FDA regulated No
Health authority Greece: Ministry of Health and Welfare
Study type Observational

Clinical Trial Summary

Posterior capsule opacification (PCO) and glistenings development is among the primary reasons for sub-optimal visual capacity following cataract extraction surgery. Primary objective of this study is to evaluate the incidence of PCO and glistenings of the popular envista MX-60 intraocular lens (Bausch + Lomb) in a random sample of cataract patients who underwent phacoemulsification at least 1 year prior to their enrollment at the study

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

Diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

Endothelial cell count less than 1900, glaucoma, IOP-lowering medications, former incisional surgery, former diagnosis of corneal disease, diabetes or autoimmune diseases

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Phacoemulsification
Phacoemulsification for cataract extraction with Envista MX-60 implantation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Democritus University of Thrace

Outcome
Type Measure Description Time frame Safety issue
Primary Glistenings Evaluation of glistenings using Scheimpflug analysis 1 year No
Primary Posterior capsule Opacification (PCO) Evaluation of PCO using EPCO software 1 year No
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