Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses After Bilateral Cataract Surgery
NCT ID: NCT06192901
Last Updated: 2024-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
8 participants
OBSERVATIONAL
2023-09-18
2023-09-22
Brief Summary
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Detailed Description
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Retro-prospective, comparative, non-interventional, non-randomized, single center study on medical devices with one follow-up visit after more than 12 months of a bilateral cataract surgery.Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study eye AT ELANA 841P
Subjects who underwent bilateral cataract surgery with the implantation of the IOL AT ELANA 841P in the first eye.
No interventions assigned to this group
Study eye AT LISA 839MP
Subjects who underwent bilateral cataract surgery with the implantation of the IOL AT LISA tri 839MP in the second eye.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patients who had an uncomplicated (no intra-operative complication) age-related cataract surgery
3. Currently implanted with an IOL model AT ELANA 841P into the capsular bag in one eye and with the IOL model AT LISA tri 839MP into the capsular bag of the other eye.
4. The postoperative visit was scheduled to be conducted more than one year after the second eye surgery.
5. Given written informed consent by patient.
Exclusion Criteria
2. Patient whose freedom is impaired by administrative or legal order
3. Concurrent participation in another drug or device investigation that could confound the outcome of this investigation.
18 Years
ALL
No
Sponsors
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Carl Zeiss Meditec AG
INDUSTRY
Responsible Party
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Locations
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Clinica Quesada
San Salvador, , El Salvador
Countries
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Other Identifiers
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AT ELANA 841P-BER-401-23
Identifier Type: -
Identifier Source: org_study_id
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