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OpenTrials
Completed

NCT Number: NCT02434588

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Ophtalmologique A. de Rotchschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bhattacharjee ring

Device

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

Primary outcomes

  1. Proportion of patients with dilated iris ≥ 6 mm

    Time frame: Immediately after ring insertion

Secondary outcomes

  1. Proportion of patients with dilated iris ≥ 6 mm after instillation of dilating eye drops

    Time frame: Immediately before ring insertion

  2. Proportion of patients with ≥ 6mm iris dilation after surgery

    Time frame: Just before ring removal

  3. Proportion of patients with iris retraction ≤ 4 mm immediately

    Time frame: Immediatly after ring removal

  4. Surgeon feeling operational conditions on an visual analogic scale

    Time frame: Immediatly after ring insertion

  5. Change for Malyugin ring during surgery

    Time frame: Just before ring insertion

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

Evaluation of an Iris Dilatation Ring in Cataract Surgery

Acronym: ADICC-ID

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 5, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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