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

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Conditions

Small Pupil

Treatments

Device: Bhattacharjee ring

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT02434588

ID-RCB 2014-A01880-47 (Other Identifier)

JFO_2014-27

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)