NCT03206983

Brief Summary

To evaluate the intraoperative stability, safety and overall efficacy of the Canabrava Ring (AJL - SPAIN) when used to expand pupils with less diameter than 5 mm and pupils with sphincter synechiae.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

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

September 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

May 18, 2017

Last Update Submit

June 29, 2017

Conditions

Small PupilCataract

Keywords

Small pupil

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    Safety of the material of the device from break, lesion of eye structures and iritis

    30 days after surgery

Secondary Outcomes (1)

  • Stability of the device during surgery

    During surgery

Study Arms (1)

Cana's Ring group

EXPERIMENTAL

The device Cana's Ring was used during cataract surgery on these patients.

Device: Cana's Ring

Interventions

Cana's RingDEVICE

The device is used during cataract surgery to help dilate small pupils (under 5mm)

Cana's Ring group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical indication for cataract surgery, age of at least 18 years, pupil diameter less than 5mm after dilation with phenylephrine and tropicamide, and lens with any degree of opacity.

You may not qualify if:

  • eyes unable to perceive light during visual acuity testing, pupils with a diameter greater than 5mm and clear lenses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MiosisCataract

Condition Hierarchy (Ancestors)

Pupil DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLens Diseases

Study Officials

  • Sergio Canabrava, MD

    Santa Casa de Misericórdia de Belo Horizonte

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2017

First Posted

July 2, 2017

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share