Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to identify ocular biomarkers that can predict the success of phacoemulsification with bilateral AT LISA try 839MP (Carl Zeiss Meditec AG) implantation to achieve satisfactory post-post-operativly spectacle-free vision. Social, biometric and patient reported outcomes will be evaluated.
Pre-operatively all patients were submitted to a comprehensive ophthalmic history and examination including, corneal topography, and aberrometry (Pentacam), biometry (IOLMaster 700, Carl Zeiss Meditec AG, Jena, Germany), specular microscopy (CEM 539, Nidek Co Ltd.), and macular and papillary Optical Coherence Tomography (Cirrus 4000 Hd OCT, Carl Zeiss Meditec AG).
All surgeries were performed by the same surgeon done by standard phacoemulsification with in-the-bag IOL placement. Patients had both eyes operated within a week.
Patients were assessed at day 1, 6, and month 3 after surgery. Six months post-operatively, refraction and slit-lamp examination was performed, and patients asked to complete the patient reported outcome questionnaire that evaluates visual satisfaction, spectacle independence and dysphoptsia like-symptoms.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pseudophakic patients with post-operative dysphotpsias | Patients who report dyshoptsias after bilateral in-the-bag implantation of a trifocal intra-ocular lens (AT LISA 839mp) |
| |
| pseudophakic patients without post-operative dysphotpsias | Patients who don't report dyshoptsias after bilateral in-the-bag implantation of a trifocal intra-ocular lens (AT LISA 839mp) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Reported Outcomes / Biometric data revision | Other | Multivariate statistical analysis will be done to identify the reported biomarkers to characterize patients into the following categories: satisfied without dysphotopsias, unsatisfied with dysphotopsias, satisfied with dysphotopsias, unsatisfied without dysphotopsias.Main outcome measures will be photic phenomena at 6 months of follow-up in correlation with the following pre-surgical parameters: macular ganglion cell complex thickness and/or total ocular and corneal higher-order aberrations (coma, trefoil, spherical aberration). Patients with known contributing factors for the development of dysphotopsias (such as residual refractive error, IOL decentration, posterior capsular opacification) will be excluded from the analyzis. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between macular ganglion cell thickness and contrast sensitivity in refractive cataract surgery patients - Identifying cutoff values that predict favourable mIOL adaptation | Evaluate if there is a correlation between macular ganglionar cell complex thickness and post-operative contrast-sensitivity at 6 months post-op | December 2023 |
| HOA detailed profile impact in dysphotopsia incidence after refractive cataract surgery - - Identifying cutoff values that predict favourable mIOL adaptation | Evaluate if specific HOA have a greater impact and association with dysphotopsias under the same IOL platform at 6 months post-op | December 2023 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Included patients presented with bilateral/unilateral cataract and pretended spectacle-free vision for all distances (far , intermediate and near).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guilherme Pires, MD | Hospital dos LusÃadas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital dos LusÃadas | Lisbon | Portugal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D015354 | Vision, Low |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007905 | Lens Diseases |
| D008919 |
| Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |