Quality of life improves after strabismus surgery in patients with ...

Quality of life improves after strabismus surgery in 1

patients with Graves’ Orbitopathy 2

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Hinke Marijke Jellema, MMedSci, CO; Elly Merckel-Timmer, CO; Roel Kloos, MD; 4

Peerooz Saeed, MD, PhD; Maarten P Mourits, MD, PhD 5

Department of Ophthalmology, University of Amsterdam, the Netherlands 6

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Running head: QoL after strabismus surgery in TED. 9

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Correspondence and reprint requests to: Hinke Marijke Jellema, Department of 13

Ophthalmology, Academic Medical Centre, Meibergdreef 9, 1105 AZ Amsterdam, the 14

Netherlands. E-mail: [email protected] 15

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WORD COUNT: 2057 17

KEYWORDS: 18

Quality of life 19

Graves’ Orbitopathy 20

diplopia 21

strabismus 22

GO-QoL 23

field of BSV 24

of 19 Accepted Preprint first posted on 3 February 2014 as Manuscript EJE-13-0973

Copyright © 2014 European Society of Endocrinology.

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ABSTRACT 25

Objective: To evaluate the influence of strabismus surgery on quality of life (QoL) in 26

Graves’ Orbitopathy (GO) patients. 27

Design: Prospective study of case series 28

Methods: Consecutive GO-patients who were scheduled for their first strabismus 29

surgery were included into the study. Patients completed the Graves’ Orbitopathy 30

Quality of Life questionnaire (GO-QoL) within 3 months before surgery and 2-4 31

months after surgery. A complete orthoptic examination, including the field of 32

binocular single vision (BSV), was performed. Clinically relevant response (CRR) of 33

the QoL was also evaluated. 34

Results: Twenty-eight patients were included. GO-QoL score for visual functioning 35

was 46.3±24.2 before surgery and 65.7±30.5 after surgery (p=0.009). The GO-QoL 36

score for appearance changed from 60.6±25.9 to 69.5±24.2 (p=0.005). After surgery, 37

the field of BSV increased from 24.3±34.8 to 68.5±36.0 points (p=0.000). A weak 38

correlation was found between the field of BSV and the visual functioning score after 39

surgery (r=0.417;p=0.034). CRR was found in 20 (71%) of the patients. Those with a 40

CRR showed a larger field of BSV (p=0.002) and better GO-QoL scores (p=0.008). 41

Conclusions: GO-QoL score increases significantly for both visual functioning and 42

appearance after the first strabismus surgery in GO-patients, showing the highest 43

improvement for the visual functioning questions. Both the GO-QoL and field of BSV 44

outcome correlate well with the CRR. 45

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INTRODUCTION 50

At least 40% of patients with Graves’ Orbitopathy suffer from diplopia, which 51

severely interferes with daily life activities like working, driving a car or reading(1-4). 52

To quantify the impact of the disease on functioning and appearance, the GO-QoL 53

questionnaire was developed into Dutch and English, validated and translated in six 54

other languages (www.eugogo.eu)(1-5). For both functioning and appearance, a total 55

of 100 points can be scored. Terwee et al (2001) studied the effect of different 56

surgical treatments on GO-QoL outcome and concluded that for strabismus surgery a 57

minimum of 6 points of change has to be considered as minimal important change. 58

However, to our knowledge, this minimum clinically important difference was not 59

confirmed by other studies. 60

The importance of QoL in evaluating the outcome of treatment has been 61

stretched by the EUGOGO group and the Amsterdam declaration (6-8). In line with 62

this, the goal of the present study is to quantify the QoL before and after strabismus 63

surgery in GO-patients. Approximately 170 new GO-patients are referred to our 64

hospital each year and about 50 (29%) patients require strabismus surgery. This 65

percentage is almost comparable to the numbers assessed in a previous study and a 66

comparable setting1. Improvement of QoL for the functional part can be established 67

by creating the largest possible field of binocular single vision (BSV)2. In the 68

literature, this measurement is scarcely used as outcome criteria (10-14). However, 69

in the clinical setting, this instrument is the best available equipment for quantifying 70

binocular single vision in other directions than primary position. The purpose of this 71

study is to evaluate the effect of strabismus surgery on the GO-QoL and to 72

investigate the correlation between the GO-QoL and the field of BSV. 73

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SUBJECTS AND METHODS 75

The study was conducted according to the principles of the Declaration of 76

Helsinki (seventh edition, October 2008, Seoul) and in accordance with the Medical 77

Research Involving Human Subjects Act (WMO).This research did not receive any 78

specific grant from any funding agency in the public, commercial or not-for-profit 79

sector. Our local ethical committee reviewed the research protocol. No approval was 80

needed, because all interventions are normally carried out within the daily routine. 81

Between December 2011 and September 2012, all consecutive GO-patients 82

(clinically and biochemically euthyroid) in our tertiary referral center who needed a 83

first strabismus surgery for diplopia were asked to participate into the study. Patients 84

with pre-existent strabismus, suppression and/or vision < 0.2 in one or both eyes 85

were excluded. An informed consent form was signed by patients who could be 86

included. Data regarding, gender, date of first diagnosis of GO, prior treatment for 87

their thyroid and eye disease and diplopia complaints before the strabismus 88

operation were recorded. A full orthoptic exam was performed within 3 months before 89

and 2-4 months after surgery. This examination included: prism covertest at near (30 90

cm) and distance (5 m), cyclodeviation on 2 ½ m with help of the Maddoxscreen and 91

the cycloforometer of Francheshetti3, measurement of ductions by a motilitymeter4, 92

eye position measured in 9 directions of gaze with the Maddoxglass and 93

Maddoxcross (Amsterdam motility scheme) and the field of BSV at 2 ½ m with help 94

of the Maddoxscreen5. A stable orthoptic examination during the last 3 months was 95

part of the inclusion criteria. The choice of surgery procedure was based on the full 96

orthoptic exam5. There were no restrictions about the type of surgical procedure. 97

Patients were operated by three orbital surgeons (RK, PS and MM). 98

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Patients completed both subscales within the GO-QoL; the visual functioning 99

and the appearance questions6. Questionnaires were self-administered, without 100

supervision, following verbal and written instructions. 101

All GO-QoL questions were scored as `severely limited' (one point), `a little 102

limited' (two points), or `not limited at all' (three points). The questions 1 - 8 and 103

questions 9 - 16 were added up to two raw scores from 8 to 24 points, and then 104

transformed to two total scores from 0 to 100 by the following formula: total score = 105

((raw score - 8)/16 x 100). For both total scores holds that higher scores indicate 106

better QoL. For questions 1 and 2, the answers `no drivers' license' or `never learned 107

to ride a bike' were scored as a missing value. When there were missing values for 108

some items, total scores were calculated for the remaining completed items. The 109

transformation was then adjusted to: total score = ((raw score - *)/ (2 x *) x 100) 110

where * is the number of completed items7. 111

The outcome of the field of BSV was scored with help of a modified score 112

system for diplopia by Holmes et al (2005)8 (Table 1). The original system is a 113

subjective score system containing the questions about double vision during 114

“reading” (4 points) and in “any position” (1 point). Also, the question if a person can 115

get rid of the double vision (-1 point) is part of the score list. Those three questions 116

were deleted and gaze position up 5º, right 20º and left 20º were added. Score points 117

were reformatted and the score system was objectively used. 118

Two orthoptists (HMJ and EMT) independently defined the clinical relevant 119

response (CRR) in each patient. Patients who showed clinical sufficient improvement 120

on the Amsterdam motility scheme were called responders. 121

Statistical analyses were done with help of SPPS 19.0 (Statistical Package for the 122

Social Sciences, Version 19.0, Chicago, Illinois, USA). Each variable was verified for 123

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normal distribution with help of the Kolmogorov-Smirnov test. If the data met the 124

requirements for normal distribution, parametric tests were applied. If not, non-125

parametric tests were used. To uncover the main and interaction effects of 126

categorical independent variables on an interval dependent variable ANOVA was 127

used. 128

129

RESULTS 130

28 patients were included into the study. Twenty-one patients were excluded. 131

13 patients because they needed a reoperation, 2 patients because of suppression 132

and thus no diplopia complaints, in 6 patients the data were incomplete. Of the 133

included patients, 8 were male (29%) and 20 were female (71%). Mean age was 134

54.5±11.2 year. All general data can be found in table 2. The type of surgery is listed 135

in Table 3. 136

The field of BSV changed from 24± 35 points to 68± 37 points (p=0.000) 137

(Figure 1). The GO-QoL for visual functioning before surgery was 46±26 points and 138

increased to 66±31 points after surgery (p=0.009). The questions about appearance 139

scored 61±26 points before and 71±22 after surgery (p=0.005)(Figure 2). A prior 140

performed decompression did not influence outcome (p=0.224). 141

Between the diplopia groups (eg intermittent, gaze dependent, constant or 142

abnormal head posture), no different outcome in score of the preoperative field of 143

BSV (ANOVA p=0.111) or the score of the GO-QoL for visual functioning (p=0.430) 144

was found. 145

A weak correlation was found between the field of BSV and the GO-QoL for 146

the visual functioning score after surgery (r=0.417;p=0.034)(Figure 3), but not for 147

appearance (r=0.180;p=0.374). 148

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CRR was found in 20 (71%) patients. The responders showed significant 149

larger fields of BSV (p=0.002) after surgery and better outcome on GO-QoL for visual 150

functioning (p=0.008) compared to the non-responders. 151

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DISCUSSION 154

The present study is, to the best of our knowledge and inspired by the 155

Amsterdam declaration, the first prospective study focusing on the QoL after 156

strabismus surgery in GO-patients. After this strabismus surgery, a significant 157

improvement of the GO-QoL score for both visual functioning and appearance 158

occurs. Both the field of BSV and GO-QoL score after surgery are significantly higher 159

in the responders group. 160

In contrast to a previous study, we found a significant higher GO-QoL score for 161

the visual functioning after surgery (mean improvement 19.4±34.5 in the present 162

study compared to mean 2.8±25.4 in the study of Terwee et al (2001))7. The 163

improvement is also higher as the mentioned 6 points of minimal clinically important 164

difference(MCID)7. The hospital setting, duration of the GO, the mean age, sex 165

distribution and number of participating patients (n=31 versus present study n=28) is 166

comparable in both studies. The improvement of the subjective score we found in this 167

study is more in line with what clinicians would expect. Terwee et al. could not clearly 168

explain why the improvement of the subjective score in het study was rather modest7. 169

Explanations for the differences of results between her and our studies are the 170

following: 1. Terwee et al. sent questionnaires 3 months after the operation per mail, 171

while our questionnaires were embedded in the treatment protocol; 2. Because the 172

questionnaire was embedded in the protocol, the response rate was 100% compared 173

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to 80% in Terwee’s study. Maybe the 20% of non-responders were the ones who 174

were asymptomatic, which influence the total score negatively; 3. For the last five 175

years strabismus surgery in GO-patients has been a focus of research in our 176

institute, which might have improved the outcome of strabismus surgery and thus the 177

outcome of the subjective evaluation. To ratify this, the CCR of Terwee et al. was 178

50% as we found 71% of patients responding to the strabismus surgery; 4. In the 179

present study only primary strabismus surgeries were included, in the study of 180

Terwee et al. this item is not specified. This could also clarify the difference between 181

the visual functioning score before surgery which is lower at baseline in the present 182

study. 183

Terwee et al. (2001) suggested that the surgery is part of a larger surgery plan 184

and that this minor invasive strabismus surgery does not change the outcome 185

significantly. However, in our study group 16 patients underwent decompression 186

surgery which counts as a major invasive surgery. GO-QoL was not different 187

between the group with or without prior decompression surgery (p=0.224). 188

In general, one should take into account that changes of the GO-QoL score 189

can be influenced by the side-effects, costs and possible available alternative 190

treatments like prism therapy. Also, total score changes in the lower end of the score 191

scale may be less important than changes to the higher end of the score7. However, 192

in contrast to the results of Terwee et al (2001) we had a lower baseline GO-QoL 193

score (due to stricter inclusion criteria) and despite of that still a higher treatment 194

effect. The side effect aspect may explain the weak correlation found between the 195

GO-QoL for visual functioning and the field of BSV after surgery. The field of BSV is 196

a clinical measurement in a setting wherein the head of the patients is being moved 197

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slowly which is different from movements in daily life (question 4 of the visual 198

functioning questionnaire 199

Another aspect which can influence the outcome of the GO-QoL is the regression to 200

the mean phenomenon9. However, by merely asking the patients to fill in the GO-QoL 201

one time before and one time after the surgery, we cannot distinguish between the 202

influence of the surgery and that of the regression of the mean. 203

It would be interesting to see if the GO-QoL outcome also applies to the 204

results 6 – 12 months after surgery for orthoptic stability, as was found in our 205

previous results. 10 Hatt et al (2012) found no changes in the health related quality of 206

life questionnaire one year after surgery (HR-QoL) in both the diplopic and non-207

diplopic patients following successful strabismus surgery11. A future study may reveal 208

if this is also applicable for the GO-patient group. 209

We are aware of the fact that we evaluated the GO-QoL and BSV scores after 210

one strabismus surgery and that for many patients multiple strabismus surgeries are 211

needed12-14, and therefore undervalue the final outcome12. For that reason, a future 212

study will focus on the effect after 2 surgeries. 213

In conclusion, the GO-QoL and the field of BSV outcome both add in their own 214

way to the information for the clinician regarding CRR in GO-patients who undergo 215

strabismus surgery. 216

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DECLARATION OF INTEREST 218

All authors state that there is no conflict of interest that could be perceived as 219

prejudicing the impartiality of the research reported. 220

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FUNDING 223

This research did not receive any specific grant from any funding agency in 224

the public, commercial or not-for-profit sector. 225

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ACKNOLEDGEMENTS 228

The authors thank Yvette Braaksma-Besselink, Yolande Everhard-Halm, and 229

Linda Groenveld, all orthoptists, for their clinical contribution to the article. Also, we 230

would like to acknowledge the effort of prof. dr. Wilmar Wiersinga with regard to the 231

discussion section. 232

233

Reference List 234

235

1. Sasim IV, Berenschot TTJM, Isterdael van C, Mourits MP. Planning health care for 236

patients with Graves' orbitopathy. Graefes Arch Clin Exp Ophthalmol 2008;246:1315-237

21. 238

2. Schotthoefer EO, Wallace DK. Strabismus associated with thyroid eye disease. Curr 239

Opin Ophthalmol 2007;18:361-5. 240

3. Klainguti G, Strickler J, Chamero J. Comparison of five methods for subjective 241

assessment of ocular cyclodeviation. Klin Monatsbl Augenheilkd 1992;200:409-13. 242

4. Mourits MP, Prummel MF, Wiersinga WM, Koornneef L. Measuring eye movements in 243

Graves' ophthalmopathy. Ophthalmology 1994;101:1341-6. 244

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5. Gutter M, van Petegem - Hellemans J, van Wijnen - Segeren I, Jellema HM. Orthopics: 245

Handbook of Practical Skills. 1th ed. Ridderkerk: Luiten Publishing; 2010. 246

6. Terwee CB, Gerding MN, Dekker FW, et al. Development of a disease specific quality 247

of life questionnaire for patients with Graves'ophthalmopathy: the GO-QOL. Br J 248

Ophthalmol 1998;82:772-9. 249

7. Terwee CB, Dekker FW, Mourits MP, et al. Interpretation and validity of changes in 250

scores on the Graves' Ophthalmopathy quality of life questionnaire (GO-QOL) after 251

different treatments. Clinical Endocrinology 2001;54:391-8. 252

8. Holmes JM, Leske DA, Kupersmith MJ. New methods for quantifying diplopia. 253

Ophthalmology 2005;112:2035-9. 254

9. Barnett AG, van der Pols J.C., Dobson AJ. Regression to the mean:what is it and how to 255

deal with it. International Journal of Epidemiology 2005;34:215-20. 256

10. Gutter M, van Petegem - Hellemans J, van Wijnen - Segeren I, Jellema HM. 257

Handleiding praktische vaardigheden orthoptie. 3 ed. Barendrecht: Uitgeverij Luiten; 258

2008. 259

11. Hatt SR, Leske DA, Liebermann L, Holmes JM. Changes in Health-Related Quality of 260

Life 1 year following strabismus surgery. Am J Ophthalmol 2012;153:614-9. 261

12. Jellema HM, Saeed P, Everhard-Halm YS, et al. Bilateral inferior rectus recession in 262

patients with Graves orbitopath: is it effective? Ophthalmic Plastic and Reconstructive 263

Surgery 2012;28:268-72. 264

13. Lyons CJ, Rootman J. Strabismus in Graves' Orbitopathy. Pediatric Endocrinology 265

Reviews 2010;7:227-9. 266

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14. Dickinson AJ, Perros P. Thyroid-Associated_Orbitopathy; who and how to treat? 267

Endocrinol Metab Clin N Am 2009;38:373-88. 268

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FIGURE LEGENDS 271

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Figure 1: The score of the field of binocular single vision before surgery (left boxplot) 273

and after surgery (right boxplot)(p=0.000). 274

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Figure 2: GO-QoL questionnaire score for visual functioning (left two bars) and 276

appearance (right two bars) before and after surgery. 277

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Figure 3: Correlation between the score of the field of BSV and the score for visual 279

functioning of the GO-QoL after surgery (r=0.417;p=0.034). 280

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Table 1: Modified diplopia / BSV score sheet

15. Diplopia is scored in all 13 standardized

positions by analyzing the field of BSV. Total score ranges from 0 (constant diplopia

everywhere) to 25 (no diplopia). The score can be multiplied by 4 to give a value between 0

and 100 if this is necessary for comparison with other instruments.

Gaze position using the Maddox tangent screen Score of BSV Score

primary position 6

up 5º 1

up 10º 1

up15º 1

up 30º 1

down 10º 2

down 30º 3

right 10º 2

right 20 2

right 30º 1

left 10º 2

left 20º 2

left 30º 1

Total

BSV = binocular single vision

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Table 2. General data

Gender 8

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male

female

Age 54,5 ±11,2

Diagnosis of GO 36.5 ±37.9 [7-216 months]

Prior treatment GTD

I 131

Thyriodectomy

Anti thyroid drugs

4

1

24

Prior treatment GO*

Lubricants

Selenium

Steroids

Radiotherapy

Other immunosuppressive treatment

Decompression

11

2

2

3

8

16

Diplopia complaints

Intermittent diplopia

Gaze dependent diplopia

Constant diplopia

Abnormal head posture

6

12

9

1

GO = Graves’Orbitopathy

GTD = Graves thyriod disease

* more therapies per patients possible

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Table 3. Surgical procedure

n (%)

Inferior rectus recession unilateral

Inferior rectus recession bilateral

Medial rectus recession unilateral

Medial rectus recession bilateral

Superior rectus recession

Superior oblique recession

6 (19)

11 (36)

4 (13)

5 (16)

3 (10)

2 (6)

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Figure 1: The score of the field of binocular single vision before surgery (left boxplot) and after surgery (right boxplot)(p=0.000). 65x52mm (600 x 600 DPI)

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Figure 2: GO-QoL questionnaire score for visual functioning (left two bars) and appearance (right two bars) before and after surgery. 58x39mm (600 x 600 DPI)

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Figure 3: Correlation between the score of the field of BSV and the score for visual functioning of the GO-QoL after surgery (r=0.417;p=0.034).

65x52mm (600 x 600 DPI)

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