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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03206983
• Other study ID #: CAN-0928-RG
• Status: Completed
• Phase: N/A
• First received: May 18, 2017
• Last updated: June 29, 2017
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: June 2017
• Source: Santa Casa de Misericórdia de Belo Horizonte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Miosis
• Small Pupil

Intervention

Device:
• Cana's Ring
The device is used during cataract surgery to help dilate small pupils (under 5mm)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santa Casa de Misericórdia de Belo Horizonte

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	Safety of the material of the device from break, lesion of eye structures and iritis	30 days after surgery
Secondary	Stability of the device during surgery	Evaluate whether the device remains stable and attached to the iris during the entire surgery	During surgery