Abstract

To assess the reliability and reproducibility of a new semiautomated evaluation method, "Rotix," for intraocular lens (IOL) rotation and to define a standardized evaluation method for future toric IOL studies. Reliability and reproducibility study. Setting: Department of Ophthalmology, Medical University of Vienna. A dataset of 25 patients with 2 consecutive follow-up visits was created to test the intra- and interrater reliability. A data test set of 10 patients including 30 pictures taken 5 minutes apart was created to test the short-term reproducibility. Evaluation of IOL rotational stability using nontoric implants in 25×2 consecutive follow-up visits. Two experienced graders performed axis evaluation 3 times in a randomized order. One experienced grader performed axis evaluation for the short-term reproducibility study. Reference landmarks at the end of operation were used to assess the IOL axis. Intra- and interrater reliability and short-term reproducibility of axis measurements. Mean standard deviation for intrarater reliability was 0.16 degrees. The intraclass correlation coefficients were 0.97 for grader 1 and 0.96 for grader 2. A very high interrater correlation of 0.95 was found. The mean individual difference between grader 1 and grader 2 was 0.061 ± 0.28 degrees. Short-term reproducibility showed a mean standard deviation of 0.22 ± 0.14 degrees. The novel semiautomated evaluation method showed an accurate inter- and intrarater reliability. Short-term reproducibility was below 0.25 degrees. The method of using nonmovable reference landmarks showed reliable results and should be used as a standard in future toric IOL studies.

Highlights

  • To assess the reliability and reproducibility of a new semiautomated evaluation method, “Rotix,” for intraocular lens (IOL) rotation and to define a standardized evaluation method for future toric IOL studies. DESIGN: Reliability and reproducibility study. METHODS: Setting: Department of Ophthalmology, Medical University of Vienna

  • Since toric IOLs evolved in the 1990s, one of their major requirements has always been rotational stability

  • The intraclass correlation coefficient (ICC) is estimated as the proportion of the variance explained by the subject divided by the total variance

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Summary

RESULTS

INTRARATER RELIABILITY: The mean standard deviations rating 3 × 25 pairs for grader 1 and grader 2 were 0.20 degrees for both graders. Median [min;max] of the standard deviation was 0.21 [0.026;0.471] degrees for grader 1 and 0.17 [0.021;0.672] degrees for grader 2, respectively. The mean individual difference between graders was 0.061 ± 0.28 degrees. The 95% confidence limits of the Bland-Altman plot were -0.70 and 0.82 degrees. The mean standard deviation of 3 measurements per patient was 0.26 ± 0.18 degrees.

DISCUSSION
Ophthalmic Implants - Intraocular Lenses - Part 7
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