Glistenings and PCO Evaluation for the Envista MX60

Completed

• Conditions: Cataract
• Interventions: Procedure: Phacoemulsification

• Registration Number: NCT02698943
• Lead Sponsor: Democritus University of Thrace

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-02
• Last Update Submitted: 2016-03-02
• Study First Posted: 2016-03-04
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Phacoemulsification	Participants who underwent phacoemulsification surgery and implantation of the Envista MX-60 IOL

Primary Outcome Measures

Name	Time	Method
Posterior capsule Opacification (PCO)	1 year	Evaluation of PCO using EPCO software
Glistenings	1 year	Evaluation of glistenings using Scheimpflug analysis