Clinical trial NCT02434588: Evaluation of an Iris Dilatation Ring in Cataract Surgery (ADICC-ID)
Official title: Evaluation of an Iris Dilatation Ring in Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Small Pupil
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-05-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Proportion of patients with dilated iris ≥ 6 mm
timeFrame: Immediately after ring insertion
Secondary outcomes:
measure: Proportion of patients with dilated iris ≥ 6 mm after instillation of dilating eye drops
timeFrame: Immediately before ring insertion
measure: Proportion of patients with ≥ 6mm iris dilation after surgery
timeFrame: Just before ring removal
measure: Proportion of patients with iris retraction ≤ 4 mm immediately
timeFrame: Immediatly after ring removal
measure: Surgeon feeling operational conditions on an visual analogic scale
timeFrame: Immediatly after ring insertion
measure: Change for Malyugin ring during surgery
timeFrame: Just before ring insertion
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rotchschild
Study officials:
References:
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.