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

NCT02434588 | Completed

• 2 other identifiers: JFO_2014-27ID-RCB 2014-A01880-47
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Pupil

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with dilated iris ≥ 6 mm

  Immediately after ring insertion

Secondary Outcomes (5)

• 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

Study Arms (1)

Bhattacharjee ring

EXPERIMENTAL

Device: Bhattacharjee ring

Interventions

Bhattacharjee ring DEVICE

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

Bhattacharjee ring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A. de Rotchschild

Paris, 75019, France

Location

Related Publications (1)

• 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.

  PMID: 34655377 DERIVED

MeSH Terms

Conditions

Miosis

Condition Hierarchy (Ancestors)

Pupil Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: May 5, 2015
• Study Start: April 14, 2015
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

FR (1)