Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers

NCT ID: NCT05748275

Last Updated: 2024-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-19

Study Completion Date

2021-09-15

Brief Summary

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To assess if the Alcon Argos Biometer utilizing the Barrett Universal II formula for IOL calculations can give a non-inferior outcome when compared to the Zeiss IOL master 700 utilizing the (PCA) with the Barrett Universal II (TK) formula, when comparing the (mean absolute prediction error of the predicted target spherical equivalencies).

Detailed Description

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Conditions

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Cataract

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Biometry measurements first with the Argos device, then the IOLMaster 700 device.

IOLMaster 700

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Biometry measurements first with the Argos device, then the IOLMaster 700 device.

IOLMaster 700

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

IOLMaster 700

Biometry measurements first with the IOLMaster 700 device, then the Argos device.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age: 50-85 years old
* 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

* Axial Length \< 22.00 and \> 26.00
* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Multack Eye Care

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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64989743

Identifier Type: -

Identifier Source: org_study_id

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