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Surgical Treatment of Severe Congenital Ptosis in

Patients Younger Than Two Years of Age Using


Preserved Fascia Lata
KYUNG IN WOO, YOON-DUCK KIM, AND YONG-HWAN KIM
 PURPOSE:

To investigate the clinical outcome of a


frontalis sling using preserved fascia lata in the treatment
of vision-obscuring congenital ptosis in patients less than
2 years of age.
 DESIGN: Retrospective, interventional case series.
 METHODS: The study was conducted in an institutional
setting and included 82 patients with visual axisobscuring
congenital ptosis. All patients underwent frontalis sling
surgery with preserved fascia lata between November
1994 and December 2008, and had a minimum followup of 6 months. Visual and surgical outcomes were
assessed by reviewing clinical photographs and medical
charts. Surgical outcomes were defined as good, fair, or
poor, based on the postoperative lid level.
 RESULTS: The mean age at surgery was 15.3 4.8
months. After a mean follow-up of 54.8 41.4 months,
64 patients (78.0%) showed good or fair surgical outcomes. Reoperation was performed in 16 of the patients
with poor or fair results. Amblyopia was treated postoperatively in 75 of the 82 patients (91.5%) and had improved
in 65 patients at the last follow-up. Postoperative entropion was identified in 5 cases, all of which were treated successfully. No other significant complications occurred.
 CONCLUSIONS: For patients younger than 2 years of age,
preserved fascia lata may be an appropriate substitute for
autogenous fascia lata in frontalis sling surgery. Its longterm stability may enable a permanent effect in a certain
proportion of patients, and may not require secondary surgery, which is common with synthetic materials. (Am J
Ophthalmol 2014;157:12211226. 2014 by Elsevier
Inc. All rights reserved.)

At a young age, in patients susceptible to amblyopia,


earlier surgery may be considered to enable the functional
development of binocular vision.2,3 The surgery could
improve chin-up head posture and developmental problems related to severe congenital ptosis. However, early surgery presents a greater surgical risk associated with general
anesthesia.4,5 In addition, visual function and levator
muscle function are difficult to properly assess in young
patients because of poor cooperation.1
For patients with congenital ptosis younger than 2 years
of age, special attention should be focused on the prevention of amblyopia. For severe ptosis in this age group, a
frontalis sling is an appropriate corrective option.
Autogenous fascia lata is considered the best material for
frontalis sling surgery.68 However, because of the difficulty
in obtaining it, alternative materials are needed, especially
for use in children below the age of 3 years.914 Although
Mersilene mesh,10,15 e-polytetrafluoroethylene,16 polyfilament cabletype sutures (Supramid sutures),9,17 Prolene
sutures,12 and silicone rods18 have been used, success rates
and complications related to synthetic materials should be
considered. Preserved fascia lata has been used for congenital ptosis of poor levator function. However, the efficacy
and long-term outcome has not been established in
patients less than 2 years of age.
We present a study of congenital ptosis correction using
preserved fascia lata in patients with amblyopia under 2
years of age. To the best of our knowledge, this is the largest
reported case series addressing this patient population. We
investigated surgical and visual outcomes and evaluated
the role of surgery at an early age for congenital ptosis.

TOSIS SURGERY IS USUALLY RECOMMENDED, WHEN

appropriate, between 3 and 5 years of age, prior to


entering school, to allow for the development of
the eyelid structure, patient cooperation, and decreased
anesthetic risks. However, the optimal timing of surgery
remains controversial.1
Accepted for publication Feb 20, 2014.
From the Department of Ophthalmology, Sungkyunkwan University
School of Medicine, Samsung Medical Center, Seoul, South Korea.
Inquiries to Yoon-Duck Kim, Department of Ophthalmology,
Sungkyunkwan University School of Medicine, Samsung Medical
Center, 50 Irwon-dong Gangnam-gu, Seoul 135-710, South Korea;
e-mail: ydkimoph@skku.edu
0002-9394/$36.00
http://dx.doi.org/10.1016/j.ajo.2014.02.041

2014 BY

METHODS
 PATIENT CHARACTERISTICS AND ASSESSMENTS:

This
was an interventional case series study. A retrospective
review was conducted in consecutive patients less than 2
years of age who had congenital ptosis with amblyopia.
The patients underwent unilateral or bilateral frontalis
sling surgery using preserved fascia lata between November
1, 1994 and December 31, 2008. The Samsung Medical
Center Institutional Review Board approved the retrospective review of patient data. The study adhered to the tenets
of the Declaration of Helsinki.

ELSEVIER INC. ALL

RIGHTS RESERVED.

1221

Surgical indications were unilateral or asymmetric bilateral ptosis severe enough to cover the center of the pupil in
1 eye and cause amblyopia. Surgery was delayed for patients
without amblyopia. Patients who were followed for less
than 6 months after surgery were excluded from the
analysis.
Amblyopia was defined as a lack of fixation by the
affected eye and objection to covering of the contralateral
eye, or as a lack of fixation as assessed by the induced tropia
test in the examined eye.19,20 During follow-up, cooperative patients were diagnosed with amblyopia when the difference of the best-corrected visual acuities (BCVA)
between the 2 eyes was greater than 2 logMAR lines on
the Snellen chart.21
Preoperative and postoperative assessments included
margin reflex distance-1 (MRD1), orthoptic evaluation,
cycloplegic refraction, and 10-prism base-down tests. Postoperative complications were also described.
The surgical outcome was judged as good, fair, or poor
based on the criteria described by Katowitz.9 A good result
was defined as a postoperative lid level resting 2-3 mm
below the superior corneal limbus without use of the frontalis muscle in bilateral cases, or within 1 mm of the opposite (normal) lid level in unilateral cases. A fair result was
defined as a lid level in the same position as described
above, but requiring the use of the frontalis muscle. A
poor result was defined as a postoperative lid level 4 mm
or more below the superior corneal limbus, even with
maximal use of the frontalis muscle. Recurrence or failure
was defined as a change in the surgical outcome from
good or fair to poor.
 SURGICAL TECHNIQUES:

All surgeries were performed


by 1 surgeon (Y.-D. Kim) using general anesthesia. Preserved fascia lata (Tutoplast; Tutogen Medical GmbH,
Neunkirchen am Brand, Germany) was used in all patients,
using a pentagonal configuration, as reported by Fox.22
Two stab incisions were made 2 mm above the eyelid
margin. Two additional stab incisions were made above
the eyebrow, and a third forehead incision was centrally
placed, 5 mm higher than the other incisions. The forehead
incision was undermined 10 mm upward for sling material
anchoring.
The preserved fascia lata was rehydrated prior to surgery,
using gentamicin sulfate in saline. Using a Wright fascia
needle, each end of the fascia strip was passed through the
incisions and pulled up from the forehead incision until
the eyelid margin was at the superior limbus. The overlapped
fascia lata were sutured together using 6-0 black silk sutures.
The ends of the fascia strips were cut short and buried
beneath the frontalis muscle, and they were anchored superiorly to the frontalis muscle with 6-0 chromic gut sutures.

 STATISTICAL ANALYSIS:

The time to recurrence of ptosis after surgery was calculated using the Kaplan-Meier survival analysis. The Wilcoxon signed rank test was used to

1222

TABLE 1. Consecutive Patients (N 82) Younger Than


2 Years of Age Who Underwent Frontalis Sling Surgery
With Preserved Fascia Lata Included in This Study

Age at
operation (m)
Mean 6 SD
Range
Sex, n (%)
Female
Male
Lid, n (%)
Right
Left

Unilateral
(n 63 Patients)

Bilateral
(n 19 Patients)

Total
(n 82 Patients)

15.0 6 4.9
6-24

16.4 6 4.4
6-22

15.3 6 4.8
6-24

19 (30.2%)
44 (69.8%)

4 (21.1%)
15 (78.9%)

23 (28.0%)
59 (72.0%)

40 (63.5%)
23 (36.5%)

19 (100%)
19 (100%)

59 (58.4%)
42 (41.6%)

TABLE 2. Surgical Results of Frontalis Sling Surgery Using


Preserved Fascia Lata in the Very Young Congenital
Ptosis Patients

Surgical results
(patients)
Good
Fair
Poor
Follow-up
(mo, mean 6 SD)

Unilateral

Bilateral

Total

39
11
13
52.5 6 39.6

12
2
5
62.6 6 46.5

51
13
18
54.8 6 41.4

compare the differences between preoperative and postoperative MRD1. The Fisher exact test was employed to
analyze categorical data, including the unilateral and bilateral ptosis group comparisons. Statistical analysis was
performed using SPSS software for Windows, version
18.0 (SPSS Inc, Chicago, Illinois, USA). Statistical significance was considered at P values <.05.

RESULTS
 PATIENT CHARACTERISTICS:

Eighty-two consecutive
patients (59 male, 23 female) were included in the analysis.
Two patients were excluded because of an insufficient
follow-up during the study periods. Nineteen of these
patients had bilateral surgery and 63 patients underwent
unilateral surgery, representing a total of 101 eyelids. Bilateral surgery was performed only for the patients who had
asymmetric bilateral ptosis with severe ptosis and amblyopia in 1 eye. The mean age of the patients at the time of
surgery was 15.3 6 4.8 months (Table 1). The mean
follow-up time was 54.8 6 41.4 months, with a range of
6-170 months (Table 2).

AMERICAN JOURNAL OF OPHTHALMOLOGY

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FIGURE 1. Preserved fascia lata used in frontalis sling surgery for a congenital ptosis patient younger than 2 years of age. A photo of a
13-month-old patient with severe ptosis obscuring the visual axis of the right eye (Left) is shown. The patient is shown at 3 months
(Center) and at 7 years after surgery (Right).

Amblyopia was identified exclusively in the ptotic eyes


of patients with unilateral ptosis. In bilateral cases, amblyopia was identified in the eye with more severe ptosis. Associated ophthalmic findings included strabismus (8/82
cases), anisometropia (16/49 cases), a combination of strabismus and anisometropia (3 cases), epiblepharon (7
cases), Marcus-Gunn jaw winking syndrome (1 case),
congenital nasolacrimal duct obstruction (1 case), and
congenital lacrimal fistula (1 case).
 SURGICAL RESULTS:

Fifty-one of the 82 cases (62.2%)


showed good results and 13 (15.9%) showed fair results at
the last follow-ups (Figure 1). Hence, a satisfactory result
was achieved in 64 of the 82 cases (78.0%) and a poor result
was recorded in 18 cases (22.0%) (Table 2). The success
rates did not statistically differ between the unilateral
and bilateral ptosis groups (50/63, 79.4%, vs 14/19,
73.7%, respectively, P .600).
The mean ptosis recurrence time in the 18 failed cases
was 27 6 23 months from the first surgery; 12 of these
patients underwent reoperation. Because 4 of the 13
patients with fair results chose to have surgical correction,
16 patients underwent reoperation (performed by 1 surgeon, Y.-D. Kim). The average age at reoperation was
56 6 23 months, and the average time after the first surgery
was 41 6 22 months.
In performing follow-up surgeries, there were neither
scar adhesions affecting the procedure nor any difficulties
related to the sling material that was previously placed.
Frontalis sling surgery was performed in 11 patients: 5
with autogenous fascia lata and 6 with preserved fascia
lata, according to parental preferences. Maximal levator
resection, with Whitnalls sling surgery, was performed in
5 patients (Table 3).
All but 1 patient retained good results after the second
surgery and throughout the 90 months of the average
follow-up period. The patient whose reoperation failed
had undergone a frontalis sling procedure with preserved
fascia lata 6 months after the first surgery. Ptosis recurred
30 months later; the patient underwent frontalis sling surgery with autogenous fascia lata 52 months after the second
surgery.
Kaplan-Meier survival analysis was performed for the
time from the initial surgery to recurrence over a 14-year

VOL. 157, NO. 6

TABLE 3. Details of 16 Patients Who Had Revision Surgery


After Frontalis Sling Operation With Preserved Fascia Lata
Method of second surgery
Frontalis sling with autogenous fascia lata
Frontalis sling with preserved fascia lata
Maximal levator resection with Whitnalls
sling surgery
Age at second surgery (mean 6 SD)
Time interval between the initial and second
surgery (mean 6 SD)

5 patients
6 patients
5 patients
56 6 23 mo
41 6 22 mo

period (170 months), and results suggested that recurrence


started to occur as soon as 1 month after surgery. However,
after a follow-up of 71 months, no recurrences were
recorded (Figure 2). The preoperative MRD1 of 0.94 6
0.91 mm (range, 3.0 to 1.5 mm) increased to 1.86 6
1.25 mm (range, 2.5 to 4.5 mm) postoperatively
(P < .0001, Figure 3).
In this study, exposure keratopathy was found to be transient and well managed with lubricants. Five patients
developed upper eyelid entropion after surgery. Entropion
was attributed to overhanging skin and orbicularis muscles,
relative to a shortened posterior lamella. Four patients
required surgical treatment (orbicularis muscle resection
and a rotational suture technique, with or without sling
recession23), and 1 improved without additional surgery.
There were 4 cases of inflammatory brow reaction, and
all cases resolved after topical antibiotic treatment. There
were no instances of stitch granuloma or extrusion of the
sling material during the follow-up period.
 VISUAL OUTCOMES:

Postoperative treatment for amblyopia was carried out in 75 of the 82 patients (91.5%). At
last follow-up, 10 of the 82 patients (12.2%) had amblyopia;
53 patients (64.6%) were examined by visual acuity tests
and 29 patients (35.4%) underwent the induced tropia test.
Among the 10 patients with amblyopia, 9 were undergoing amblyopia treatment at the time of last follow-up. The
average age of these 10 patients at the last follow-up was
49.6 months (range, 18-93 months), which was 35.1 months
(range, 6-82 months) after the initial surgery. Amblyopia
was diagnosed with a visual acuity test in 4 of these patients
and with the induced tropia test in 6 patients.

PRESERVED FASCIA LATA FOR SEVERE CONGENITAL PTOSIS

1223

FIGURE 2. Kaplan-Meier survival curve illustrating satisfactory surgical results following frontalis sling surgery with
preserved fascia lata in 82 patients younger than 2 years of
age with severe congenital ptosis (101 total eyelids).

DISCUSSION
THE RESULTS OF THIS STUDY DEMONSTRATE THAT FRONTA-

lis sling surgery using preserved fascia lata was beneficial for
the management of ptosis in patients younger than 2 years
of age. Satisfactory surgical results were achieved in 78.0%
of the cases throughout the mean follow-up period of
54.8 months. Early surgery and amblyopia treatment were
shown to provide beneficial effects on visual rehabilitation.
Previous studies showed that the highest success rates
were achieved by using autogenous fascia lata in frontalis
sling surgery. However, autogenous fascia lata was not suitable for younger patients because it was difficult to harvest
from patients under 3 years of age.14,24
Synthetic materials may provide alternatives to autogenous fascia lata use. The advantages of using silicone rods as
sling materials includes elasticity, little tissue reaction, and
easy adjustment.25 The recurrence rates using silicone rods
were reported to be between 7% and 44%, but longterm effects on periocular tissues have not been established.13,26,27
In comparative studies of silicone rods vs preserved fascia
lata, the use of silicone rods provided better cosmetic
results and lower recurrence rates than preserved fascia
lata.27,28 However, the average age of the patients in
these 2 studies was 4.6 years and 55 months, respectively,
suggesting the need for further determination of success
rates using silicone rods in children less than 2 years old.
Suture materials have the advantages of commercial
availability, relative ease of insertion compared with fascia
lata, inert properties, and reversibility. However, poor surgical results have been reported at long-term follow-up.9,17
Therefore, use of suture materials should only be temporary.9
1224

FIGURE 3. Preoperative and postoperative margin reflex


distance-1 (MRD1) changes are shown for patients younger
than 2 years of age who underwent frontalis sling surgery using
preserved fascia lata for severe congenital ptosis (P < .0001).

There are some important considerations when using


preserved fascia lata as a sling material for the repair of
congenital ptosis in patients under 2 years of age. During
surgery, it is important to ensure that the prepared fascia
strip is cut parallel to the longitudinal direction of the fascia, not cut obliquely, because the quality of the material
may vary. The preserved fascia lata may be too stiff and
bulky for optimal use in the eyelids of very young patients.
Care should be taken while pulling the material out
through the pretarsal space, so as not to cut through the
pretarsal skin or muscle. Postoperative scarring related to
the sling material, which could complicate reoperative
quality, did not occur in our case series. Similar cases
have not been previously reported. There was also the possibility of transmission of infectious diseases when using
allografts.
Various techniques have been introduced in frontalis
sling surgery, including single-loop8,9,26,29 vs double-loop
configurations30,31 and closed- vs open-sky methods.32 A
single-loop pentagonal design was adopted for our case
series because it was easy to perform in young children,
whose eyelids did not provide enough area for the 3 stab
incisions that were required for double-loop surgery with
preserved fascia lata.
Long-term stability is another factor to consider when
using preserved fascia lata as a sling material. Preserved fascia lata removed after a long time of implantation was
microscopically well preserved and infiltrated by fibroblasts
and blood vessels.33,34 Wilson and Johnson demonstrated
an increased number of failures over time; the success
rate of surgery fell from 90% at 2-3 years to 50% at 8-9
years of follow-up.35 The lyophilization method used and
the involvement of several surgeons in this study may
have lowered the long-term success rate. OReilly and

AMERICAN JOURNAL OF OPHTHALMOLOGY

JUNE 2014

associates reported that no changes in the eyelid position


were observed in the patients at more than 18 months
post surgery.3 However, an 18-patient study was considered
to be too small to provide statistically conclusive results. In
a study by Esmaeli and associates, the recurrence rate was
21% in 132 eyelids, during an average follow-up of 10
years.36 The recurrence rate for patients younger than 3
years of age was higher, but the difference was not statistically significant.
In the present study, surgical failure was initially
recorded at 1 month postoperatively, and a continuous increase in the number of failures occurred until month 71.
After this period, however, the eyelid positions were stable
and no additional failures were observed.
Therefore, preserved fascia lata can provide an alternative to autogenous fascia lata as a suspensory material for
young patients with severe congenital ptosis. In some
patients, the procedure may exert a permanent effect
and may not require secondary surgery, as is commonly
observed with the use of suture material for a frontalis
sling.

Amblyopia rates of 20%,1 50%,37 and 75%38 have been


reported for surgical cases of congenital ptosis. The variations in rates may reflect the test methods employed, age
of the patient, and severity of ptosis. As reported by Lin
and associates, surgical correction of congenital ptosis
may aid in the treatment of amblyopia. The study showed
that preoperative amblyopia rates of 37.5% dropped to
5% postoperatively, a result comparable with our data.20
The strengths of our study are that all the surgeries were
performed by 1 surgeon, the data were collected at 1 institution, and the study represents, to date, the largest series of
patients under 2 years of age. The limitations of the study
are that it was a single-center study, had a retrospective
design, and did not have a control group of amblyopia
patients treated solely with visual rehabilitation. Additionally, the data were not comprehensive because all of the patients were too young; thus we could not perform thorough
ophthalmic examinations in all cases.
Overall, our results highlight the long-term efficacy of
preserved fascia lata in frontalis sling surgery for patients
younger than 2 years of age.

ALL AUTHORS HAVE COMPLETED AND SUBMITTED THE ICMJE FORM FOR DISCLOSURE OF POTENTIAL CONFLICTS OF INTEREST
and none were reported. The authors indicate no funding support. Contributions of the authors: design of the study (Y.D.K., K.I.W.); conduct of the study
(K.I.W., Y.H.K.); collection of data (Y.H.K.); management, analysis, and interpretation of data (Y.D.K., K.I.W., Y.H.K.); preparation of the manuscript
(K.I.W., Y.H.K.); review and approval of the manuscript (Y.D.K.).

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Biosketch
Kyung In Woo, MD is a Professor of Ophthalmology at Sungkyunkwan University and Samsung Medical Center, Seoul,
Korea. Dr Woo received her medical degree from Seoul National University. She completed an ophthalmology
residency at Seoul National University Hospital and an oculoplastic surgery fellowship at Samsung Medical Center. She
did clinical research at Medical College of Wisconsin, Milwaukee, WI and Barnes-Jewish Hospital, St. Louis, MO. Her
main research interests are pediatric and lacrimal diseases and oncology.

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