Glistenings and PCO Evaluation for the Envista MX60

NCT ID: NCT02698943

Last Updated: 2016-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-02-29

Brief Summary

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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

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Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

Participants who underwent phacoemulsification surgery and implantation of the Envista MX-60 IOL

Phacoemulsification

Intervention Type PROCEDURE

Phacoemulsification for cataract extraction with Envista MX-60 implantation

Interventions

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Phacoemulsification

Phacoemulsification for cataract extraction with Envista MX-60 implantation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Democritus University of Thrace

OTHER

Sponsor Role lead

Responsible Party

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Georgios Labiris

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios Labiris, MD, PhD

Role: STUDY_CHAIR

Assistant Professor

Other Identifiers

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320/2-3-2016

Identifier Type: -

Identifier Source: org_study_id

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