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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

Tracking Information
First Submitted Date  ICMJE April 14, 2015
First Posted Date  ICMJE May 5, 2015
Last Update Posted Date August 31, 2018
Actual Study Start Date  ICMJE April 14, 2015
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
Proportion of patients with dilated iris ≥ 6 mm [ Time Frame: Immediately after ring insertion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
  • Proportion of patients with dilated iris ≥ 6 mm after instillation of dilating eye drops [ Time Frame: Immediately before ring insertion ]
  • Proportion of patients with ≥ 6mm iris dilation after surgery [ Time Frame: Just before ring removal ]
  • Proportion of patients with iris retraction ≤ 4 mm immediately [ Time Frame: Immediatly after ring removal ]
  • Surgeon feeling operational conditions on an visual analogic scale [ Time Frame: Immediatly after ring insertion ]
  • Change for Malyugin ring during surgery [ Time Frame: Just before ring insertion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of an Iris Dilatation Ring in Cataract Surgery (ADICC-ID)
Official Title  ICMJE Evaluation of an Iris Dilatation Ring in Cataract Surgery
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Pupil
Intervention  ICMJE Device: Bhattacharjee ring
Insertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery
Study Arms  ICMJE Experimental: Bhattacharjee ring
Intervention: Device: Bhattacharjee ring
Publications * Salviat F, Febbraro JL, Zuber K, Yavchitz A, Moran S, Gatinel D. Evaluation of a uniplanar pupil expansion ring in small-pupil cataract surgery: a feasibility study. Int Ophthalmol. 2021 Oct 16. doi: 10.1007/s10792-021-02065-9. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2018)
25
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2015)
20
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02434588
Other Study ID Numbers  ICMJE JFO_2014-27
ID-RCB 2014-A01880-47 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor  ICMJE Fondation Ophtalmologique Adolphe de Rothschild
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP