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

Small Pupil Clinical Trial

— ADICC-ID  

Official title:

Evaluation of an Iris Dilatation Ring in Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434588
• Other study ID #: JFO_2014-27
• Secondary ID: ID-RCB 2014-A018
• Status: Completed
• Phase: N/A
• Start date: April 14, 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cataract
• Miosis
• Small Pupil

Intervention

Device:
• Bhattacharjee ring
Insertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rotchschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with dilated iris = 6 mm		Immediately after ring insertion
Secondary	Proportion of patients with dilated iris = 6 mm after instillation of dilating eye drops		Immediately before ring insertion
Secondary	Proportion of patients with = 6mm iris dilation after surgery		Just before ring removal
Secondary	Proportion of patients with iris retraction = 4 mm immediately		Immediatly after ring removal
Secondary	Surgeon feeling operational conditions on an visual analogic scale		Immediatly after ring insertion
Secondary	Change for Malyugin ring during surgery		Just before ring insertion