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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02270879
Enrollment
156
Registered
2014-10-21
Start date
2014-06-30
Completion date
2014-07-31
Last updated
2014-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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.

Interventions

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

Sponsors

Centro Hospitalar do Baixo Vouga
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Second eye mean absolute error (mean of the absolute value of the prediction error)6 weeks after date of cataract surgery

Secondary

MeasureTime frame
Percentage of second eyes with a post-operative refraction within ±0.50 D and ±1.00 D of the targeted refraction6 weeks after date of cataract surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026