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

August 30, 2018 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Evaluation of an Iris Dilatation Ring in Cataract Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Ophtalmologique A. de Rotchschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bhattacharjee ring
Device: Bhattacharjee ring
Insertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with dilated iris ≥ 6 mm
Time Frame: Immediately after ring insertion
Immediately after ring insertion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2015

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JFO_2014-27
  • ID-RCB 2014-A01880-47 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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