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
About this trial
This is an interventional treatment trial for Small Pupil
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)
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
NCT ID
NCT02434588
First Posted
April 14, 2015
Last Updated
August 30, 2018
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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
Learn more about this trial
Evaluation of an Iris Dilatation Ring in Cataract Surgery (ADICC-ID)
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