Clinical Trials Directory

Trials / Completed

CompletedNCT02270879

Multi-formula Optimization of Second Eye Refinement According to Direction of the Prediction Error of the First Eye

Status
Completed
Phase
Study type
Observational
Enrollment
156 (actual)
Sponsor
Centro Hospitalar do Baixo Vouga · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Prediction errors for the first (PE1) and second eyes (PE2) were obtained in the intra-ocular lens power calculation for 4 formulae (HofferQ, SRK II, SRK/T and Holladay 1). The optimal correction factor for each formula was determined as the one resulting in the lowest mean absolute error. A similar analysis was performed in the negative and positive PE1 subgroups.

Detailed description

Retrospective case series study. A retrospective chart review was conducted, which included demographics (age and gender) and several parameters for both the first and second eyes: surgery date, axial length, keratometric corneal power in 2 meridians, predicted intra-ocular lens (IOL) power recommended for plano target in each formulae (HofferQ, SRK II, SRK/T and Holladay 1), implanted IOL power, predicted post-operative refraction for the implanted IOL for the 4 formulae, observed post-operative refraction in spherical equivalent and post-operative best corrected visual acuity. The prediction error was calculated for the first eye (PE1) as the difference between the observed post-operative refraction in spherical equivalent and the predicted post-operative refraction by the IOL Master for the implanted IOL. This was obtained for the 4 formulae. The prediction error for the second eye (PE2) was obtained in a similar fashion. The optimal partial adjustment for second eye refinement was obtained subtracting a portion of the PE1 from the PE2 (PE2-xPE1, where 0≤x≤1) for the 4 formulae. The optimal correction factor was determined for all formulae by using an array of different proportions of PE1 that were applied to the second eye. The values ranged from 10% to 100%, with increments of 10% each.

Conditions

Interventions

TypeNameDescription
PROCEDUREPhacoemulsification cataract surgeryPhacoemulsification of cataract (opacified lens) using clear corneal approach. Implantation of a intra-ocular lens in the capsular bag

Timeline

Start date
2014-06-01
Primary completion
2014-07-01
Completion
2014-07-01
First posted
2014-10-21
Last updated
2014-10-21

Source: ClinicalTrials.gov record NCT02270879. Inclusion in this directory is not an endorsement.