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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Fondation Ophtalmologique Adolphe de Rothschild

Dates:
Date Received: April 14, 2015
Date Started: April 14, 2015
Date Completion: May 2017
Last Updated: February 7, 2017
Last Verified: February 2017