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Completed

NCT Number: NCT02270879

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phacoemulsification Cataract Surgery

Procedure

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

Primary outcomes

  1. 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

  1. Percentage of second eyes with a post-operative refraction within ±0.50 D and ±1.00 D of the targeted refraction

    Time frame: 6 weeks after date of cataract surgery

Sponsors and collaborators

Lead sponsor

Centro Hospitalar do Baixo Vouga

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 21, 2014
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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