Effects of Corneal Toxicity and Conjunctival Injection of Preservative-free 0.1% Fluorometholone after Pediatric Strabismus Surgery

Yeon Kim Su; Young Chun Bo

doi:10.3341/jkos.2017.58.7.846

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Su and Bo: Effects of Corneal Toxicity and Conjunctival Injection of Preservative-free 0.1% Fluorometholone after Pediatric Strabismus Surgery

Original Article

J Korean Ophthalmol Soc 2017;58(7):846-851.

Published online: 8 September 2017

DOI: https://doi.org/10.3341/jkos.2017.58.7.846

Effects of Corneal Toxicity and Conjunctival Injection of Preservative-free 0.1% Fluorometholone after Pediatric Strabismus Surgery

Yeon Kim Su, M.D., Young Chun Bo, M.D., PhD

Department of Ophthalmology, Kyungpook National University School of Medicine, Daegu, Korea

Address reprint requests to Bo Young Chun, MD, PhD Department of Ophthalmology, Kyungpook National University Hospital, #130 Dongdeok-ro, Jung-gu, Daegu 41944, Korea Tel: 82-53-420-5818, Fax: 82-53-426-6552 E-mail: byjun424@hotmail.com

* This study was supported by Hanlim Pharmaceuticals for clinical research funding and eye drops.

Received 16 February 201726 April 2017 Accepted 20 June 2017

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

To compare the degrees of conjunctival injection and corneal toxicity between preservative and preservative-free top-ical 0.1% fluorometholone after strabismus surgery.

Methods

A randomized, prospective clinical study was performed to compare the degrees of conjunctival injection and corneal toxicity between preservative and preservative-free topical 0.1% fluorometholone after strabismus surgery. Sixty-one patients with intermittent exotropia were included in this study. They were told to apply antibiotic eye drops (ED) and either preservative or preservative-free topical 0.1% fluorometholone (F1) three times a day. Measurements of the degrees of conjunctival injection and corneal toxicity were performed at postoperative 1 week and 3 weeks each.

Results

Seventeen patients (34 eyes) were included in group 1 (preservative F1) and twenty patients (40 eyes) were included in group 2 (preservative-free F1). The average pixel value (measured via the Image J software) representing the degree of con-junctival injection was 31,732 ± 9,946 in group 1 and 38,347 ± 12,189 in group 2 at postoperative 1 week, while the average pixel value was 10,150 ± 4,493 in group 1 and 11,836 ± 4,290 in group 2 at postoperative 3 weeks. There was a significant difference between the decrease in pixel value for the two groups (p = 0.040). There was no significant difference in the mean value of the Oxford stain score between the two groups at postoperative 3 weeks, however the mean questionnaire scores in group 2 were significantly lower than in group 1 (p = 0.001).

Conclusions

Preservative-free 0.1% fluorometholone ED demonstrated a larger decrease in the degree of conjunctival injection than for preservative ED after strabismus surgery. Therefore, the use of preservative-free steroid ED may be beneficial for de-creasing both conjunctival injection and postoperative discomfort following strabismus surgery.

Keywords: Conjunctival injection, Fluorometholone, Preservative-free, Strabismus surgery

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Figure 1.

Method of image analysis. (A) The conjunctival image was taken by image capture system and was recorded as an JPG image. (B) An region of interest (ROI) (red square in A) was selected as the evaluation area. (C) A binarized image of the ROI.

Table 1.

Demographic characteristics of patients

	Group 1(preservative F1)	Group 2(preservative-free F1)	p-value
Number of patients	17	20
Age (range)	7.9 (5-12)	7.4 (5-12)	0.208^†
Sex (M/F)	8/9	9/11	0.862^*

F1 = fluorometholone 0.1%; M = male; F = female.

^* No statistical significance using a χ2 for independence.

^† No statistical significance using a student t-test (p < 0.05).

Table 2.

Comparison of mean value of numbers of pixels which demonstrates degree of conjunctival injection between the two groups

	Group 1(preservative F1)	Group 2(preservative-free F1)	p-value^*
Postoperative 1 week	31,732 ± 9,946	38,347 ± 12,189	0.012
Postoperative 3 weeks	10,150 ± 4,493	11,836 ± 4,290	0.104
Amount of decrease	21,582 ± 8,716	26,510 ± 11,153	0.040

Values are presented as mean ± SD. F1 = fluorometholone 0.1%.

^* Mann-Whitney U-test (p < 0.05).

Table 3.

Comparison of presence of dellen and Oxford stain score (OSS) at postoperative 3 weeks between the two groups

	Group 1(preservative F1)	Group 2(preservative-free F1)	p-value^*
Dellen
Preoperative	0	0
Postoperative 3 weeks	0	0
OSS
Preoperative	0.471 ± 1.02	0.40 ± 0.71	0.728
Postoperative 3 weeks	0.225 ± 0.62	0.178 ± 0.48	0.413

Values are presented as mean ± SD. F1 = fluorometholone 0.1%.

^* Mann-Whitney U-test (p < 0.05).

Table 4.

Comparison of mean value of questionnaire scores at postoperative 3 weeks between the two groups

	Group 1(preservative F1)	Group 2(preservative-free F1)	p-value^*
Total scores (range)	10.21 (9-23)	4.875 (1-13)	0.001
F1 = fluorometholone 0.1%.

^* Mann-Whitney U-test (p < 0.05).

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