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临床试验/NCT02270879
NCT02270879已完成不适用

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

Centro Hospitalar do Baixo Vouga0 个研究点目标入组 156 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
156
主要终点
Second eye mean absolute error (mean of the absolute value of the prediction error)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

结局指标

主要结局

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

时间窗: 6 weeks after date of cataract surgery

次要结局

  • 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)

研究者

发起方
Centro Hospitalar do Baixo Vouga
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pedro Gil

MD, MSc

Centro Hospitalar do Baixo Vouga

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