Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers
NCT ID: NCT05748275
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
80 participants
OBSERVATIONAL
2021-07-19
2021-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Argos, Then IOLMaster 700
Biometry measurements first with the Argos device followed by the IOLMaster 700 device.
Argos
Biometry measurements first with the Argos device, then the IOLMaster 700 device.
IOLMaster 700
Biometry measurements first with the IOLMaster 700 device, then the Argos device.
IOLMaster 700, Then Argos
Biometry measurements first with the IOLMaster 700 device followed by the Argos device.
Argos
Biometry measurements first with the Argos device, then the IOLMaster 700 device.
IOLMaster 700
Biometry measurements first with the IOLMaster 700 device, then the Argos device.
Interventions
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Argos
Biometry measurements first with the Argos device, then the IOLMaster 700 device.
IOLMaster 700
Biometry measurements first with the IOLMaster 700 device, then the Argos device.
Eligibility Criteria
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Inclusion Criteria
* Clinically Significant Cataracts that interfere with daily activities
* Patient is able to understand and able to consent to informed consent
* Patient is able to come to all postoperative visits and agrees to follow up at 30 days -2/+14 days
* Patient undergoing cataract surgery, with implantation of the Alcon SN60WF lens in the capsular bag.
Exclusion Criteria
* Corneal Astigmatism \> +1.00 Diopters
* CCTS: \< 490 and \> 600
* Prior Refractive Surgery: RK, PRK, LASIK, INTACTS
* History of contact lens use: Soft lenses within 2 months of surgery, RGP within 60 months of surgery
* Corneal Disease: Keratoconus, Corneal Dystrophies, Any prior corneal Surgery, Prior infections
* Retinal Disease: Macular Pathology, CSCR, CME, Macular Degeneration, Drusen, Retinal Detachment, TPPV, SB, prior IVT, Prior PRP or Focal Laser, Diabetic Retinopathy
* History of Uveitis
* POAG: Undergoing any concomitant MIGS procedure- iStent, Omni, iTrack, Hydrus, etc
* Enrollment in any prior clinical trial within 2 years
* Systemic Disease that in the investigator's opinion may affect outcome
* Currently Pregnant or Breastfeeding
* Severe Dry Eye
* Tear Osmolarity \> 320mOsms/L (Moderate)
* Any Surgical Complication(s)
* IOL implanted outside of the capsular bag /capsular damage /weakness /CTR placement
50 Years
85 Years
ALL
No
Sponsors
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Multack Eye Care
OTHER
Responsible Party
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Principal Investigators
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Sam Multack, D.O.
Role: PRINCIPAL_INVESTIGATOR
Multack Eye Care
Locations
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Multack Eye Care
Frankfort, Illinois, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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64989743
Identifier Type: -
Identifier Source: org_study_id
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