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Clinical Trials/NCT02270879
NCT02270879CompletedNot Applicable

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

Centro Hospitalar do Baixo Vouga0 sites156 target enrollmentStarted: June 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
156
Primary Endpoint
Second eye mean absolute error (mean of the absolute value of the prediction error)

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients having performed bilateral cataract surgery between 1st October 2012 and 24th April 2014 in a single ophthalmological center (Centro Hospitalar Baixo Vouga, Portugal)

Exclusion Criteria

  • •Inadequate follow-up
  • •Incomplete medical records
  • •Previous or combined ocular surgery
  • •Manual extracapsular cataract extraction and not phacoemulsification
  • •Corneal sutures
  • •Implantation of any other IOL type different from Abbott Tecnis® 1-piece IOL (Abbott Laboratories Inc., Illinois, USA), ZCB00
  • •IOL implanted in the sulcus
  • •Intra or postoperative complication
  • •Post-operative best corrected visual acuity worse than 5/10
  • •Corneal astigmatism>3.00 D

Outcomes

Primary Outcomes

Second eye mean absolute error (mean of the absolute value of the prediction error)

Time Frame: 6 weeks after date of cataract surgery

Secondary Outcomes

  • Percentage of second eyes with a post-operative refraction within ±0.50 D and ±1.00 D of the targeted refraction(6 weeks after date of cataract surgery)

Investigators

Sponsor
Centro Hospitalar do Baixo Vouga
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pedro Gil

MD, MSc

Centro Hospitalar do Baixo Vouga

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