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Trans epithelial versus epithelium-off corneal cross-linking for the treatment
1. Trans-epithelial Versus Epithelium-off Corneal
Cross-linking for the Treatment of Progressive
Keratoconus: A Randomized Controlled Trial
NIENKE SOETERS, ROBERT P.L. WISSE, DANIEL A. GODEFROOIJ
AMERICAN JOURNAL OF OPHTHALMOLOGY, MAY 2015
2. PURPOSE
To compare the clinical effects and safety of trans-epithelial corneal cross-
linking (CXL) to epithelium-off (epi-off) CXL in progressive keratoconus.
3. DESIGN: Randomized clinical trial (noninferiority).
METHODS: Patients received either trans-epithelial CXL with
Ricrolin TE (n [ 35) or epi-off CXL with isotonic riboflavin (n [ 26)
in 1 academic treatment center, using a simple unrestricted
randomization procedure. The main outcome measure was
clinical stabilization of keratoconus after 1 year, defined as a
maximal keratometry (Kmax) increase <1 diopter (D).
4. SURGICAL TECHNIQUE:
In the trans-epithelial CXL group
Local anesthetic eye drops (oxybuprocaine 0.4% and tetracaine 1%)
were applied 3 times during 5 minutes, and Ricrolin TE solution (consisting
of riboflavin 0.1% eye drops with Dextran T500 15 mg and EDTA; SOOFT
Italia) were instilled every 2 minutes for 15 minutes. Next, an eyelid
speculum was placed and a silicone ring was positioned between the
eyelids; the ring was filled with Ricrolin TE and used to retain a Ricrolin
‘‘pool’’ on the cornea. After 15 minutes, the silicone ring was removed,
the cornea was rinsed with balanced salt solution, and pachymetry was
performed. UVA irradiation was performed during 30 minutes, while
Ricrolin TE solution was reapplied to the cornea every 5 minutes.
5. Epi-off CXL technique
was performed following the Dresden protocol, adjusted with the
avoidance of the eyelid speculum during riboflavin instillation. Epithelial
removal (9-mm) was performed using a blunt knife. After pachymetry
measurements, isotonic riboflavin 0.1% solution with 20% Dextran (Medio
Cross) was applied every 3 minutes for 30 minutes, with no eye lid
speculum in place
6. RESULTS
Average Kmax was stable at all visits in the transepithelial group, while after epi-
off CXL a significant flattening of 1.2–1.5 D was demonstrated from the 3-month
follow-up onwards. The trend over time in Kmax flattening was significantly
different between the groups.
There was significant different trend in corrected distance visual acuity (CDVA),
with a more favorable outcome in thetransepithelial group.
In the transepithelial group no complications were observed while in epi-off
group, 4 eyes (15%) developed complications owing to healing problems (sterile
infiltrate, herpes keratitis, central haze, and stromal scar).
7.
8.
9.
10. DISCUSSION
This trial showed that transepithelial cross-linking with EDTA riboflavin* was
less effective to halt keratoconus progression after 1 year compared to
epithelium-off cross-linking.
11. indicators for a CXL effect
General indicators (with stabilization being the main purpose) are a
1. visible demarcation line,
2. a flattened keratometry, and
3. reduced pachymetry.
12. No demarcation line was found in the transepithelial CXL group and the
average central keratometry, maximal keratometry, and pachymetry were
unchanged after treatment.
The average Kmax flattening after 1 year in the epi-off group in this study
was more pronounced (-1.5 D).
13.
14. CONCLUSION
This study showed that although transepithelial CXL was a safe procedure
without epithelial healing problems, 23% of cases showed a continued
keratoconus progression after 1 year
Editor's Notes
Department of Ophthalmology, University Medical Center Utrecht, Utrecht, Netherlands
The standard technique of CXL
was first applied in 1998 and consists of an epithelial
removal, after which riboflavin eye drops and ultraviolet-
A (UVA) light are applied.
.The rationale for the removal of the epithelium was described as allowing adequate penetration of riboflavin into the stromal tissue,where it absorbs the UVA light and produces the actual
cross-linking between collagen fibrils in the corneal
stroma
When pachymetry was <400 mm, hypo-osmolar riboflavin
was additionally applied every 20 seconds for 5 minutes and
repeated up to 2 times until the required pachymetry value
of >400 mm was achieved. With an eyelid speculum in
place, UVA irradiation was performed during 30 minutes,
during which isotonic riboflavin drops were given every
5 minute
In both groups, the post-CXL medication consisted of
antibiotic eye drops (Vigamox, 5 mg/mL, and preservative-free artificial tears (Duratears Free,
2%; Alcon Nederland BV) and were used for 4 weeks, while
nonsteroidal anti-inflammatory drops (Nevanac 0.1%;
Alcon Nederland BV) were used during the first week. Starting 1 week after CXL, topical steroids (fluorometholone
0.1% drops; Allergan Nederland BV) were applied
twice a day for 2 weeks. Bcl in epi off
can be explained by the haze formation at the 1-month
follow-up in the epi-off group, which was noted after
epithelium removal.31 Another explanation for CDVA
and keratometry changes at the 1-month follow-up could
be the remodeling of epithelium (in keratoconus, the
epithelium layer is thinnest at the cone, and the epithelium
thickness profile can reestablish a smoother surface).
(Ricrolin TE), although showing no adverse events,
Recent developments of transepithelial CXL in another
manner, for instance by iontophoresis, showed increased
uptake of riboflavin into the stroma, and resulted in
stable and decreased keratometry and improved UDVA
or CDVA after 1 year in small groups of patients (20–22
eyes)
The fact that these indicators
were absent in the transepithelial CXL group suggests
that this treatment was not sufficiently effective in
halting progressive keratoconus. However, if we compare
the mean Kmax value after 1 year in our transepithelial
CXL group (þ0.3 D) to those of the untreated control
groups of 3 randomized controlled trials (þ1.2 D,16 0.1
D (18 months),30 and þ0.3 D18), the effect is debatable.
Another notable finding in our transepithelial CXL group
was a significant CDVA increase, in addition to a significantly
increased cylinder. This indicates that there might
be something going on in transepithelial CXL with Ricrolin
TE after all.