Evaluation of an Iris Dilatation Ring in Cataract Surgery (ADICC-ID) (ADICC-ID)
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|ClinicalTrials.gov Identifier: NCT02434588|
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : August 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Small Pupil||Device: Bhattacharjee ring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of an Iris Dilatation Ring in Cataract Surgery|
|Actual Study Start Date :||April 14, 2015|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||July 2018|
|Experimental: Bhattacharjee ring||
Device: Bhattacharjee ring
Insertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery
- Proportion of patients with dilated iris ≥ 6 mm [ Time Frame: Immediately after ring insertion ]
- Proportion of patients with dilated iris ≥ 6 mm after instillation of dilating eye drops [ Time Frame: Immediately before ring insertion ]
- Proportion of patients with ≥ 6mm iris dilation after surgery [ Time Frame: Just before ring removal ]
- Proportion of patients with iris retraction ≤ 4 mm immediately [ Time Frame: Immediatly after ring removal ]
- Surgeon feeling operational conditions on an visual analogic scale [ Time Frame: Immediatly after ring insertion ]
- Change for Malyugin ring during surgery [ Time Frame: Just before ring insertion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434588
|Fondation Ophtalmologique A. de Rotchschild|
|Paris, France, 75019|