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

Primary Purpose

Small Pupil

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bhattacharjee ring
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Pupil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Fondation Ophtalmologique A. de Rotchschild

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bhattacharjee ring

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients with dilated iris ≥ 6 mm

Secondary Outcome Measures

Proportion of patients with dilated iris ≥ 6 mm after instillation of dilating eye drops
Proportion of patients with ≥ 6mm iris dilation after surgery
Proportion of patients with iris retraction ≤ 4 mm immediately
Surgeon feeling operational conditions on an visual analogic scale
Change for Malyugin ring during surgery

Full Information

First Posted
April 14, 2015
Last Updated
August 30, 2018
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02434588
Brief Title
Evaluation of an Iris Dilatation Ring in Cataract Surgery (ADICC-ID)
Acronym
ADICC-ID
Official Title
Evaluation of an Iris Dilatation Ring in Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 14, 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Pupil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bhattacharjee ring
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Bhattacharjee ring
Intervention Description
Insertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery
Primary Outcome Measure Information:
Title
Proportion of patients with dilated iris ≥ 6 mm
Time Frame
Immediately after ring insertion
Secondary Outcome Measure Information:
Title
Proportion of patients with dilated iris ≥ 6 mm after instillation of dilating eye drops
Time Frame
Immediately before ring insertion
Title
Proportion of patients with ≥ 6mm iris dilation after surgery
Time Frame
Just before ring removal
Title
Proportion of patients with iris retraction ≤ 4 mm immediately
Time Frame
Immediatly after ring removal
Title
Surgeon feeling operational conditions on an visual analogic scale
Time Frame
Immediatly after ring insertion
Title
Change for Malyugin ring during surgery
Time Frame
Just before ring insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Fondation Ophtalmologique A. de Rotchschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34655377
Citation
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. 2022 Feb;42(2):489-496. doi: 10.1007/s10792-021-02065-9. Epub 2021 Oct 16.
Results Reference
derived

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

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