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

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ClinicalTrials.gov Identifier: NCT03206983
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Santa Casa de Misericórdia de Belo Horizonte

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.

Condition or disease Intervention/treatment Phase
Small Pupil Cataract Device: Cana's Ring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of the Canabrava/s Pupil Expansion Device in Cataract Surgery With Small Pupils: The First 30 Cases
Actual Study Start Date : September 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Cana's Ring group
The device Cana's Ring was used during cataract surgery on these patients.
Device: Cana's Ring
The device is used during cataract surgery to help dilate small pupils (under 5mm)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206983


Sponsors and Collaborators
Santa Casa de Misericórdia de Belo Horizonte
Investigators
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Study Chair: Sergio Canabrava, MD Santa Casa de Misericórdia de Belo Horizonte

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Responsible Party: Santa Casa de Misericórdia de Belo Horizonte
ClinicalTrials.gov Identifier: NCT03206983     History of Changes
Other Study ID Numbers: CAN-0928-RG
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Santa Casa de Misericórdia de Belo Horizonte:
Small pupil

Additional relevant MeSH terms:
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Cataract
Miosis
Lens Diseases
Eye Diseases
Pupil Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms