Accuracy of Intra Ocular Lens CARLEVALE Calculation
Sponsor
Poitiers University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05368870
Collaborator
(none)
40
1
2
20
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the accuracy of intra ocular lens power calculation using the new Carlevale sutureless scleral fixation posterior chamber intra ocular lens.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Retrospective comparison of refractive spherical equivalent predicted before surgery and measured after surgery in patient who underwent implantation of an sutureless scleral fixation posterior chamber intra ocular lens between October 2019 and Avril 2022 in the ophthalmology department of Poitiers Hospital and La Rochelle Hospital.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
40 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Carlevale Sutureless Scleral Fixation Intra Ocular Lens : Retrospective Study of Power Calculation Accuracy.
Actual Study Start Date
:
Apr 1, 2022
Anticipated Primary Completion Date
:
May 1, 2022
Anticipated Study Completion Date
:
Jun 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Carlevale implantation
|
Procedure: Carlevale implantation
Vitrectomy and Carlevale implantation
|
Outcome Measures
Primary Outcome Measures
- Prediction error [Between Month 1 and Month 6]
Difference between the measured and predicted post-operative refractive spherical equivalent for the intra oculaire lens power implanted
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- All patients who underwent implantation of Carlevale between Octobre 2019 and Avril 2021 in the ophtalmologie department of Poitiers hospital and La Rochelle hospital
Exclusion Criteria:
- No data about post surgery refraction.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre hospitalier universitaire | Poitiers | Vienne | France | 86000 |
Sponsors and Collaborators
- Poitiers University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT05368870
Other Study ID Numbers:
- Observational retrospective
First Posted:
May 10, 2022
Last Update Posted:
May 10, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: