NCT02698943

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

March 2, 2016

Last Update Submit

March 2, 2016

Conditions

Cataract

Keywords

cataract; intraocular lens; posterior capsule opacification; glistening; ENVISTA

Outcome Measures

Primary Outcomes (2)

  • Glistenings

    Evaluation of glistenings using Scheimpflug analysis

    1 year

  • Posterior capsule Opacification (PCO)

    Evaluation of PCO using EPCO software

    1 year

Study Arms (1)

Study Group

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

Procedure: Phacoemulsification

Interventions

PhacoemulsificationPROCEDURE

Phacoemulsification for cataract extraction with Envista MX-60 implantation

Study Group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with senile cataract

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Georgios Labiris, MD, PhD

    Assistant Professor

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 4, 2016

Study Start

September 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 4, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share