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The goal of this observational study is to evaluate whether different intraocular lens (IOL) injectors affect surgical outcomes in patients aged 40 and older undergoing cataract surgery. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pioli™ rD | Participants receiving the pioli™ preloaded injector with the rD model, used for IOL powers < 25.5 diopters | ||
| pioli™ Plus rD | Participants receiving the pioli™ Plus preloaded injector with the rD model, used for IOL powers < 25.5 diopters | ||
| lioli™ <25.5D | Participants receiving the lioli™ manually loaded injector for IOL powers < 25.5 diopters | ||
| pioli™ rC | Participants receiving the pioli™ preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters | ||
| pioli™ Plus rC | Participants receiving the pioli™ Plus preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters | ||
| lioli™ ≥25.5D | Participants receiving the lioli™ manually loaded injector for IOL powers ≥ 25.5 diopters |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Corneal Incision Size | Measurement of the corneal incision before and after intraocular lens (IOL) insertion using each type of injector. Difference in incision size (in mm) | Day of surgery (intraoperative) |
| Incidence of Adverse Events | Number and type of ocular and non-ocular adverse events (serious and non-serious) recorded from initiation of the intra-ocular lens (IOL) implantation, both intraoperative and early postoperative period (up to 30 days). Percentage of participants with any AE | From surgical incision to end of surgery, assessed up to 120 minutes (intraoperative), and From end of surgery until postoperative day 30 (postoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Duration | Time required to insert the IOL using each type of injector. Time in seconds (measured with a stopwatch) | During surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (aged 40 and older) scheduled for routine cataract surgery using phacoemulsification and implantation of an Asqelio™ monofocal intraocular lens. Participants must have clear intraocular media except for the presence of cataract and meet standard clinical criteria for lens implantation. Patients are recruited from a single ophthalmology center in Spain and are typical candidates for conventional cataract surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrián Hernández Martínez, MD, PhD | Contact | +34 954 933 930 | oft.ahm@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Adrián Hernández Martínez, MD, PhD | OftalVist Sevilla | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica OftalVist Sevilla | Recruiting | Seville | Sevilla | 41018 | Spain |
The study does not include a plan to share individual participant data (IPD), as data will be anonymized and used solely for internal analysis and regulatory reporting
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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