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Glistenings and PCO Evaluation for the Envista MX60

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ClinicalTrials.gov Identifier: NCT02698943
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
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

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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02698943


Sponsors and Collaborators
Democritus University of Thrace
Investigators
Study Chair: Georgios Labiris, MD, PhD Assistant Professor

Responsible Party: Georgios Labiris, Assistant Professor, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT02698943     History of Changes
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:
Cataract
Capsule Opacification
Lens Diseases
Eye Diseases