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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of an Iris Dilatation Ring in Cataract Surgery

Conditions
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Small Pupil

Intervention / Treatment
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* Device: Bhattacharjee ring


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bhattacharjee ring<br> | Device: Bhattacharjee ring<br>* Insertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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