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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05748275
• Other study ID #: 64989743
• Status: Completed
• Start date: July 19, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: February 2023
• Source: Multack Eye Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Multack Eye Care	Frankfort	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Multack Eye Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean absolute prediction error (D)		1 month postoperatively
Secondary	Percentage of eyes with absolute prediction error 0.5 D or less		1 month postoperatively
Secondary	Median absolute prediction error (D)		1 month postoperatively