Trials / Completed
CompletedNCT02434588
Evaluation of an Iris Dilatation Ring in Cataract Surgery (ADICC-ID)
Evaluation of an Iris Dilatation Ring in Cataract Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bhattacharjee ring | Insertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery |
Timeline
- Start date
- 2015-04-14
- Primary completion
- 2018-06-01
- Completion
- 2018-07-01
- First posted
- 2015-05-05
- Last updated
- 2018-08-31
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02434588. Inclusion in this directory is not an endorsement.