NCT02642211

Brief Summary

Prospective randomized trial in patients requiring cataract surgery in which IOP, angle anatomy and other demographic and clinical data are compared. Subjects randomized to both MSICS and phakoemulsification

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2014

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
Last Updated

January 7, 2016

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

December 19, 2015

Last Update Submit

January 5, 2016

Conditions

CataractGlaucoma

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure lowering

    intraocular pressure measured with aplanation tonometry

    6 months

Secondary Outcomes (1)

  • Angle anatomy

    6 months

Study Arms (2)

phako

ACTIVE COMPARATOR

eyes receiving phakoemulsification for cataract surgery

Procedure: cataract surgery

MSICS

ACTIVE COMPARATOR

Eyes undergoing manual small incision cataract surgery

Procedure: cataract surgery

Interventions

cataract surgeryPROCEDURE

Eyes (one eye per patient) randomized to either phacoemulsification and intraocular lens insertion or small incision cataract surgery and intraocular lens insertion

MSICSphako

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CataractGlaucoma

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesOcular Hypertension

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2015

First Posted

December 30, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 7, 2016

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will share

plan to share in paper form and at national meetings