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Evaluation of an Iris Dilatation Ring in Cataract Surgery (ADICC-ID) (ADICC-ID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434588
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Study Description
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Brief Summary:

During cataract surgery, it is necessary to dilate the iris in order to remove the crystalline lens and position the implant. The diameter of the optical implant being 6 mm, in case of capsulorhexis crystalline access 5.5 mm, the expansion should be at least 6 mm.

At pre-operative consultation, the iris is always dilated by instillation of eye drops and measured at the slitlamp. For patients with an inadequate dilation, the intervention requires the use of a mechanical dilatation device.

This study aims to assess the value of an alternative dilatation ring to Malyugin ring, which can be inserted and removed through an incision of less than 2 mm in diameter, due to its size smaller than that of the Malyugin ring.

Our hypothesis is that this Bhattacharjee ring ensures sufficient and stable iris dilation during surgery, enabling implant placement in good conditions.


Condition or disease Intervention/treatment Phase
Small Pupil Device: Bhattacharjee ring Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of an Iris Dilatation Ring in Cataract Surgery
Actual Study Start Date : April 14, 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bhattacharjee ring Device: Bhattacharjee ring
Insertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with dilated iris ≥ 6 mm [ Time Frame: Immediately after ring insertion ]

Secondary Outcome Measures :
  1. Proportion of patients with dilated iris ≥ 6 mm after instillation of dilating eye drops [ Time Frame: Immediately before ring insertion ]
  2. Proportion of patients with ≥ 6mm iris dilation after surgery [ Time Frame: Just before ring removal ]
  3. Proportion of patients with iris retraction ≤ 4 mm immediately [ Time Frame: Immediatly after ring removal ]
  4. Surgeon feeling operational conditions on an visual analogic scale [ Time Frame: Immediatly after ring insertion ]
  5. Change for Malyugin ring during surgery [ Time Frame: Just before ring insertion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with programmed cataract surgery under topical or local anesthesia
  • Need to use a dilatation ring during operation, highlighted by iris dilatation ≤ 6 mm on slitlamp, after mydriatic solution and 10% phenylephrine eye drops instillation

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Patient's refusal to participate in the study
  • Patient non covered by health insurance
  • Complete iridectomy
  • Tearing of iris sphincter
  • Important posterior synechiae (when the iris is attached to the anterior surface of the implant)
  • Anterior chamber very deep (depth of the anterior chamber lower than 1mm after injection of the viscous product)
Contacts and Locations
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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): NCT02434588


Locations
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France
Fondation Ophtalmologique A. de Rotchschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02434588    
Other Study ID Numbers: JFO_2014-27
ID-RCB 2014-A01880-47 ( Other Identifier: ANSM )
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Miosis
Cataract
Lens Diseases
Eye Diseases
 Pupil Disorders
Neurologic Manifestations
Nervous System Diseases