Efficacy of the Canabrava/s Pupil Expansion Device in Cataract Surgery With Small Pupils: The First 30 Cases

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03206983

Enrollment

Registered

2017-07-02

Start date

2014-09-30

Completion date

2016-09-30

Last updated

2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Small Pupil

Keywords

Small pupil

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.

Detailed description

In this consecutive case series, 30 eyes of 29 patients underwent cataract surgery using a new disposable small-pupil expansion device, Canabrava's Ring (AJL Ophthalmic, Spain). It is the first iris expansion ring produced with indents that do not align with each other in the superior and inferior regions, resulting in a small vertical length (0.4mm) that minimizes risk of endothelial contact. All eyes had poorly preoperatively dilated pupils of less than 5mm. Fifteen eyes had significant infective or traumatic pathology preoperatively. Vertical and horizontal pupil diameters were evaluated pre-, intra- and 1 month postoperatively, and were used to calculate pupil circumference. Intraoperative and postoperative pupil circumference comprised the primary outcomes of interest.

Interventions

DEVICECana's Ring

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse events	30 days after surgery	Safety of the material of the device from break, lesion of eye structures and iritis

Secondary

Measure	Time frame	Description
Stability of the device during surgery	During surgery	Evaluate whether the device remains stable and attached to the iris during the entire surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026