COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Glistenings and PCO Evaluation for the Envista MX60

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02698943
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Information provided by (Responsible Party):
Georgios Labiris, 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

Condition or disease Intervention/treatment
Cataract Procedure: Phacoemulsification

Layout table for study information
Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Glistenings and Posterior Capsule Opacification Following Envista MX60 Intraocular Lens Implantation
Study Start Date : September 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
Study Group
Participants who underwent phacoemulsification surgery and implantation of the Envista MX-60 IOL
Procedure: Phacoemulsification
Phacoemulsification for cataract extraction with Envista MX-60 implantation

Primary Outcome Measures :
  1. Glistenings [ Time Frame: 1 year ]
    Evaluation of glistenings using Scheimpflug analysis

  2. Posterior capsule Opacification (PCO) [ Time Frame: 1 year ]
    Evaluation of PCO using EPCO software

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with senile cataract

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02698943

Sponsors and Collaborators
Democritus University of Thrace
Layout table for investigator information
Study Chair: Georgios Labiris, MD, PhD Assistant Professor
Layout table for additonal information
Responsible Party: Georgios Labiris, Assistant Professor, Democritus University of Thrace Identifier: NCT02698943    
Other Study ID Numbers: 320/2-3-2016
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Georgios Labiris, Democritus University of Thrace:
cataract; intraocular lens; posterior capsule opacification; glistening; ENVISTA
Additional relevant MeSH terms:
Layout table for MeSH terms
Capsule Opacification
Lens Diseases
Eye Diseases