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Completed

NCT Number: NCT03206983

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

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.

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Key information

Conditions

Small Pupil Cataract Eye Diseases Lens Diseases Miosis Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pupil Disorders Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cana's Ring

Device

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

Primary outcomes

  1. Incidence of adverse events

    Time frame: 30 days after surgery

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

Secondary outcomes

  1. Stability of the device during surgery

    Time frame: During surgery

    Evaluate whether the device remains stable and attached to the iris during the entire surgery

Sponsors and collaborators

Lead sponsor

Santa Casa de Misericórdia de Belo Horizonte

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2017
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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