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

NCT03206983 — Not applicable, Completed, 29 participants, Santa Casa de Misericórdia de Belo Horizonte
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RegistryNCT03206983
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment29 (Actual)
SponsorSanta Casa de Misericórdia de Belo Horizonte (Other)
ConditionsSmall Pupil, Cataract
InterventionsCana's Ring (Device)
Datesstart 2014-09-01, primary completion 2016-09-01, completion 2016-09-01, first posted 2017-07-02, last updated 2017-07-02

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Cana's Ring groupExperimentalDevice: Cana's RingThe device Cana's Ring was used during cataract surgery on these patients.
  • Cana's Ring (Device): The device is used during cataract surgery to help dilate small pupils (under 5mm)

+Outcome measures

Primary outcomes

  • Incidence of adverse events [30 days after surgery]: Safety of the material of the device from break, lesion of eye structures and iritis

Secondary outcomes

  • Stability of the device during surgery [During surgery]: Evaluate whether the device remains stable and attached to the iris during the entire surgery

+Eligibility

Sex: All, ages: 18 Years to 85 Years, accepts healthy volunteers

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

+Investigators

My Notes