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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB 2014-A01880-47 | Other Identifier | ANSM |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bhattacharjee ring | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bhattacharjee ring | Device | Insertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with dilated iris ≥ 6 mm | Immediately after ring insertion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondation Ophtalmologique A. de Rotchschild | Paris | 75019 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34655377 | Derived | 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. |
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| ID | Term |
|---|---|
| D015877 | Miosis |
| ID | Term |
|---|---|
| D011681 | Pupil Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |