23 24
Prezado(a) Senhor(a); 25
A pesquisa com sua participação VOLUNTÀRIA, fará a medida de rima 26
palpebral ou da pele de recobre o olho, na situação antes e depois da cirurgia para 27
correção do desvio ocular – o estrabismo. 28
Nesse tratamento, um efeito nessa rima; pode ocorrer de forma mínima. A 29
medida desse efeito será feita através de fotografias tiradas antes e três meses 30
depois da cirurgia. Um programa de computador ajudara a medir. Assim 31
saberemos se ocorre um aumento ou diminuição da rima ou do espaço entre as 32
pálpebras. 33
O risco principal para a cirurgia será de efeitos indesejáveis da anestesia; e 34
risco de infecção para o olho. A fim de evitar riscos; faremos exames antes e no dia 35
de sua realização. Se qualquer risco for detectado, a cirugia será reagendada. 36
Durante a pesquisa; não utilizaremos novos medicamentos e novas formas de 1
operar. 2
A pesquisa não afetará o resultado do seu tratamento. E seu direito NÃO 3
QUERER PARTICIPAR. E seu direito; caso aceite participar, SAIR QUANDO 4
QUISER DA PESQUISA. Qualquer decisão sua – NÃO AFETARA SEU 5
TRATAMENTO. A qualquer momento também o senhor (a) poderá solicitar as 6
fotografias através de cópias. O total de fotos poderá ser limitado pelo senhor(a). 7
Sua imagem na fotografia não será utilizada para outro fim. Não divulgaremos a 8
sua imagem em internet, TV, jornais; revistas ou filmes. As fotografias ficarão 9
guardadas no arquivo do hospital. 10
Caso o senhor (a) tenha algum prejuízo com esta pesquisa, no que se refere 11
a sua vinda ao hospital para acompanhamentos, comunique isso ao pesquisador 12
responsável. 13
Eu, _________________________________, RG: _______________declaro 14
ter sido informado e concordo em participar como voluntário da pesquisa acima. 15
Ou 16
Eu, ________________________________________ R.G. 17
_____________________, responsável legal por 18
_________________________________________________, R.G. _____________, 19
declaro ter sido informado e concordo com sua participação no projeto de pesquisa 20 acima descrito. 21 22 23 Niterói, ________de _________ de _________ 24 25 26 27
Nome e assinatura do paciente ou seu responsável legal Nome e assinatura do responsável por obter o consentimento
28 29 30 31 Testemunha Testemunha 32 33 34 35
9.4 Parecer do Comitê de Ética em Pesquisa da Faculdade de 1 Medicina/HUAP. 2 3 4 5 6
1 10.0 Artigo Final 2 3 4 Abstract 5 6 7
BACKGROUND: Previous reports suggest that bilateral recession of the medial 8
or lateral rectus muscles for horizontal strabismus may affect the palpebral 9
fissure width. Very little quantitative date is available in the literature about this 10
important side effect of strabismus surgery. DESIGN: Interventional case series. 11
METHODS: We compared preoperative and postoperative palpebral fissure 12
widths in 59 prospective nonrandomized consecutive strabismus surgeries. A 13
digital imaging process analysis of the lid fissure width was used before and 14
after all unilateral or bilateral recessions of the medial or lateral rectus muscles 15
for the correction of esotropia (ETMRR group) and exotropia (XTLRR group). 16
RESULTS: The difference between preoperative and postoperative palpebral 17
fissure widths was statistically significant (p < .0001, t-test) in the two treatment 18
groups. CONCLUSIONS: Unilateral or bilateral horizontal recession of the 19
rectus muscles for horizontal comitant strabismus may result in widening of the 20
palpebral fissure. Comparisons with other conditions causing a similar effect on 21
the palpebral fissure width are currently under study. 22 23 24 25 Introduction 26 27 28
Recession of the medial or lateral rectus muscles, the most commonly used 29
procedures for the correction of horizontal comitant strabismus, have few 30
documented side effects on the ocular adnexa1. Observational studies have 31
shown postoperative changes in the palpebral fissure width for both vertical2 32
and horizontal 3 strabismus surgery. Vertical rectus muscle surgery appears to 33
affect the position of the contiguous eyelid, because the inferior rectus and 34
superior rectus have attachments to the lower and upper eyelid respectively. 35
Moving the posterior attachments of the horizontal rectus muscles can also 36
induce changes in the relative position of the eye in the orbit and widening of 37
the palpebral fissure 4-5-6. Another risk factor for lid width change that cannot be 38
ignored is the possibility of adverse side effects induced by the anesthetics 39
employed in the surgery7. Finally, an important complication of any strabismus 40
procedure, the Slipped Muscle, may result in widening of the palpebral fissure in 41
the affected eye 8-9. Potential change in lid fissure width must be taken into 42
account when combined eyelid surgery and recession of both rectus muscles 43
are performed in the same-setting .10-11 44
45
46
Patients and Methods 47
48 49
Fifty nine patients were selected at the Strabismus Division of Hospital 1
Universitário Antonio Pedro/Niterói/RJ/Brazil between January 2007 and 2
December 2009. Strabismus surgery for exotropia was performed in 17 patients 3
(8/9 = bilateral/unilateral recession), and for esotropia in 42 patients (37/5 4
bilateral/unilateral recession). Operated eyes were subdivided into two groups: 5
one group submitted to unilateral or bilateral recession of the medial rectus 6
muscle (ETMRR group) and a second group submitted to unilateral or bilateral 7
lateral rectus muscle recession (XTLRR group). Conventional surgery was 8
performed on all eyes by a single surgeon with direct reattachment of the 9
horizontal rectus muscles at the planned scleral site. Patients with sensory 10
strabismus, incomitant squint, paralytic strabismus, restrictive strabismus and 11
reoperations were excluded from the study groups. No eyes were submitted to 12
any other surgical procedure other than the LR or MR recession. In other words, 13
oblique muscle surgery and muscle ressections when indicated were excluded 14
from the study. Patients with insufficient follow-up data were also excluded. All 15
of the patients included underwent a detailed ophthalmologic examination, 16
including best-corrected visual acuity, fundus and anterior segment evaluation. 17
Preoperative and postoperative deviations were measured by the alternating 18
cover test with prisms using an accommodative target for distance and near, if 19
possible, or the Krimsky light reflex test at near distance for the very young 20
patients. All measurements were performed with loose prisms (LUNEAU- 21
FRANCE) by the same examiner (LIMA). 22
Digital photographs were taken preoperatively and three months 23
postoperatively. The patients were positioned with their chin and forehead 24
resting on the slit lamp with a metric ruler fixed to the forehead rest. Three 25
photographs were taken of each eye pre-operatively with one eye fixating a 26
distant target while the other eye was covered. For the postoperative data three 27
photographs were taken with both eyes uncovered and fixating the same distant 28
target. The Open Source ImageJ12 (National Institutes of Health-USA) for pc 29
systems was used for the Digital Process Image (PDI) analysis. Baseline data 30
and the surgical differences of the lid fissure width between the preoperative 31
and postoperative photographs were compared with a Paired Student’s t-test 32
(for mean value comparison) S-Plus version 8.0 (ITC labs/UVa) 13 statistical 33
program. 34
This study was performed with the approval of the Review Board Committee for 35
Ethics in Research of the Hospital Universitário Antonio Pedro (CEP-CMM- 36
HUAP) and this study was performed in compliance with resolutions n º 196/96, 37
of the National Council of Health of the Ministry of Health of Brazil for health 38 research. 39 40 41 Results 42 43 44
Seventy nine eyes were subjected to medial rectus recession for the correction 45
comitant esotropia (ETMRR group) and twenty five eyes were subjected to 46
lateral rectus recession for exotropia (XTLRR group). The mean age of surgery 47
was 8.16 (range:2-42 years old) for the ETMRR group and 18,47 (range 3-55 48
years old) for the XTLRR group. The mean preoperative deviation was 47.23 ∆ 49
(range 25-70 ∆ ) for the ETMRR group and 52 ∆ (range 25-75 ∆ ) for the 50
XTLRR group. Table 1 gives the descriptive parameters of the eyes, as well as 1
the palpebral fissure width (PFW) measurements before and after surgery; 2
deviation measurements before and after surgery and the amounts of surgical 3
recessions used for the 2 groups. The mean difference between pre and 4
postoperative PFW was 0.96mm (range: 0, 65-2.5 mm) e 1.03 mm (range 0, 19- 5
3.2mm) for the ETMRR and XTLRR groups respectively. The mean standard 6
difference for the two groups was 0.119/0.118 respectively. The differences 7
between the pre e postoperative PFW were statistically significant (p < 0,0001, 8
t-test) in both groups (ETMRR and XTLRR). Graphs 1 and 2 show the 9
distributions of the preoperative PFW and PFW standard differences. 10 11 12 13 Conclusions 14 15 16
This study suggests that unilateral or bilateral horizontal rectus muscle 17
recession induces a postoperative widening of the palpebral fissure width in 18
preoperative comitant esotropic and exotropic squints (in attempted fixation 19
gaze). In some patients, particularly in patients treated unilaterally, this effect 20
can be cosmetically noticeable and the patient should therefore be warned of 21
this potential surgical side effect. This potential side effect could also be used 22
for the patients benefit when combined lid and strabismus surgical approaches 23
are attempted. In addition, special attention should be given to iatrogenic 24
widening of the palpebral fissure width when there is an important duction deficit 25
in the action of the operated muscle. 26
27 28 29