Small Pupil
Conditions
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.
Interventions
DEVICEBhattacharjee ring
Insertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with dilated iris ≥ 6 mm | Immediately after ring insertion |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed