The integrity of corneal epithelium is essential for various corneal functions, including but not limited to clarity and immunity [
Different factors, both internal and external, may contribute, positively or negatively, to this process [
D-Panthenol, the precursor of vitamin B5, possesses an established positive effect on epithelium healing in general [
Recently, ophthalmic preparations have included D-panthenol in its ingredients, in order to get benefit from its healing effect, at the corneal level [
In this study, we assessed the effect of D-panthenol 2% ophthalmic preparation (Augé Vitamin™, Köln, Germany) on corneal epithelial healing, when the defect is induced during a surface laser ablation, intended for vision correction.
This is a prospective study which included 45 patients. Each patient underwent a surface ablation procedure in both eyes. One eye received D-panthenol (provitamin B5) in propyl-methyl cellulose (Augé Vitamin™), and the other eye received artificial tear drops in the form of carboxy-methyl cellulose (Refresh™- Allergan- Irvine-California). For purpose of randomization, the first 23 patients received Augé Vitamin™ in the right eye and Refresh™ in the left. The second 22 patients received the opposite. Eyes with Augé Vitamin™ were considered as cases (group A), and those who received Refresh™ served as control group (group B).
The study was conducted in the Eye Consultants Center, Jeddah, Saudi Arabia.
Patients were enrolled into the study if they were suffering from ametropia and seeking vision correction. Age should be within 18–45 years at time of surgery. BSCVA should reach at least 20/20 in each eye. Eyes should be otherwise free from any pathology in terms of ocular surface (dry eye, inflammation, corneal scar, vascularization, etc.), anterior segment (cataract, glaucoma, uveitis, etc.), and posterior segment ones. Eyes should also possess corneas not susceptible for postoperative ectasia.
Cases were examined for visual acuity with Snellen’s chart. Refraction was performed as manifest and cycloplegic. Anterior segment was examined by slit lamp and posterior segment by dilated fundoscopy. Cases were examined for eligibility for laser vision correction by corneal tomography (Pentacam™, Oculus, Germany) to detect the susceptibility for postoperative corneal ectasia.
After prepping and draping, the conjunctival sac was washed with ample amount of isotonic saline. Corneal epithelium was mechanically debrided after installation of 20% ethyl alcohol in an 8.0 mm well for 20 seconds. Laser ablation was performed using Wavelight® EX-500 platform (Alcon laboratories, Inc.). Ablation was centered on the pupil, and axis of astigmatism was respected by a pupil tracker and iris and limbus registration system.
Ablation depth was determined according to error of refraction, optical zone (OZ), and the profile of ablation. In myopic eyes, refraction was adjusted according to a nomogram, adding 0.25 D for each −3.0 D < −3.0 D of total refraction (sphere + cylinder), an extra 0.25 D for individuals >35 years, to compensate for hyperopic shift. Hyperopic eyes were treated without modification of manifest refraction.
Standard optical zone was 6.5 mm. 7.0 mm was chosen for hyperopic cases, and 6.0 mm was chosen for cases <500
After ablation, a cellulose sponge soaked with 0.02% MMC was applied for 1 second for each 2
All surgeries were performed by same surgeon (IH).
In addition to the tested agents mentioned above (Augé Vitamin™ and Refresh™), patients received only antibiotic eye drops, Gatifloxacin (Zymaxid™, Allergan, Irvine, CA). All drops were prescribed Qid. To avoid corneal infection, patients were instructed to remain indoors during the epithelial defect stage (except for examination visits). They were also instructed to avoid touching the eye, washing face, and exposure to pollution and smoke.
Patients were received for examination daily, for 3 days, until complete epithelial defect closure. During these visits, UCVA was tested, percentage of epithelial closure was estimated, and assessment of patient comfort was done, for each eye separately.
UCVA was measured in presence of −0.25 D bandage contact lens, assessed in 20-feet scale and then converted into Log MAR scale for statistical purposes.
Percentage of epithelial defect healing was assessed by the same examiner (IH).
Subjective assessment for comfort was evaluated by asking the patient to evaluate pain and itching in each eye, giving the score of 0 for no discomfort at all and 5 to severe intolerable symptoms.
After complete epithelial defect closure, bandage contact lens was removed. Patients were instructed to resume normal life activities except exposure to UV rays in form of sun light for 4 months.
Antibiotic drops were discontinued and replaced by topical corticosteroids, rimexolone 1% (Vexol™, Alcon, Fort Worth, Texas) Qid for 2 months. Tested agents were continued for 2 months.
Patients were received for examination at 1, 2, and 3 weeks and 1 and 2 months from the surgery day.
They were tested for UCVA similar to the first postoperative stage.
Residual subjective refraction was measured, and residual cylinder was considered as a sign for corneal regularity.
Corneal haze was evaluated in terms of presence and level (epithelial or stromal).
All patients signed an informed consent, explaining in details the procedure and the nature of the study. An approval was received from the ethical committee in the center prior to initiation of the study. The study respected the tenets of Declaration of Helsinki.
Statistical analyses were performed using SPSS software, version 12 (SPSS Inc., Chicago, Illinois). Descriptive analysis was performed by calculating mean±standard deviation and range for quantitative data. For qualitative data, frequencies were represented by a number and percentage. For parametric values, a between-group comparison was performed with Student’s
Among the 45 patients included in this study, 37 (82.2%) were females and 8 (17.7%) were males. Mean age of patients was 29.3 ± 6.9(21–43) years.
Group A and B were matched in terms of preoperative refraction, ablation zone size, and depth of ablation. Table
Preoperative and operative data.
Group A | Group B |
| |
---|---|---|---|
Preoperative sphere (D) | −2.9 ± 2 (−6.5–1.5) | −2.4 ± 2.6 (−6.25–4.0) | >0.05 |
Preoperative cylinder (D) | −0.68 ± 0.4 (−1.75–0) | −0.66 ± 0.47 (−1.5–0) | >0.05 |
Ablation zone (mm) | 6.25 ± 0.35 (6–7) | 6.25 ± 0.35 (6–7) | >0.05 |
Ablation depth ( |
51.5 ± 19.5 (19–90) | 50.6 ± 20.7 (19–95) | >0.05 |
At the first postoperative stage (epithelial defect), both groups showed
Uncorrected visual acuity (log MAR), with statically nonsignificant difference (
Rate of epithelial defect healing (%) with statically nonsignificant difference (
First postoperative stage (epithelial defect).
Day 1 | Day 2 | Day 3 | ||
---|---|---|---|---|
UCVA (log MAR) | Group A | 0.22 ± 0.18 (−0.1–0.5) | 0.51 ± 0.31 (0.2–0.9) | 0.51 ± 0.33 (0.1–1.0) |
Group B | 0.24 ± 0.24 (−0.2–0.7) | 0.52 ± 0.29 (0.2–1.0) | 0.54 ± 0.28 (0.15–1.0) | |
|
>0.05 | >0.05 | >0.05 | |
|
||||
Healing (%) | Group A | 52.8 ± 16.1 (30–80) | 94.2 ± 12.2 (60–100) | 99.1 ± 2.8 (90–100) |
Group B | 50.8 ± 16.9 (15–80) | 96.5 ± 4.4 (90–100) | 99.1 ± 0.28 (99–100) | |
|
>0.05 | >0.05 | >0.05 | |
|
||||
Comfort | Group A | 3.33 ± 1.4 (0–5) | 1.71 ± 1.34 (0–4) | 0.58 ± 0.9 (0–3) |
Group B | 3.61 ± 1.09 (2–5) | 1.63 ± 1.43 (0–4) | 0.5 ± 1.0 (0–3) | |
|
>0.05 | >0.05 | >0.05 |
At the second postoperative stage (epithelial and stromal remodeling), both groups showed similar results, except for a
Residual cylinder (D), with statically nonsignificant difference (
The D-Panthenol group showed rapid initial clarity of epithelial haze (1 and 2 weeks) and a nearly similar pattern of clarity with control, hence forward (Figures
Haze in D-panthenol group.
Haze in control group.
Second postoperative stage (epithelial and stromal remodeling).
Week 1 | Week 2 | Week 3 | Month 1 | Month 2 | ||
---|---|---|---|---|---|---|
UCVA (log MAR) | Group A | 0.1 ± 0.19 (−0.1–0.7) | 0.63 ± 0.39 (0–1) | 0.09 ± 0.1 (0–0.3) | 0.07 ± 0.13 (−0.1–0.4) | 0.03 ± 0.08 (−0.1–0.15) |
Group B | 0.19 ± 0.19 (0–0.7) | 0.32 ± 0.29 (0–0.8) | 0.13 ± 0.11 (0–0.3) | 0.11 ± 0.16 (−0.1–0.4) | 0.02 ± 0.1 (−0.1–0.15) | |
|
<0.05 |
>0.05 | >0.05 | >0.05 | >0.05 | |
|
||||||
Residual cylinder (D) | Group A | 0.42 ± 0.43 (0–1.25) | 0.76 ± 0.54 (0–2.0) | 0.59 ± 0.32 (0.25–1.0) | 0.73 ± 0.5 (0–2.0) | 0.62 ± 0.46 (0–1.5) |
Group B | 0.7 ± 0.6 (0–1.75) | 0.85 ± 0.77 (0–1.75) | 0.87 ± 0.29 (0.5–1.25) | 0.76 ± 0.52 (0–2.0) | 0.56 ± 0.32 (0.25–1.25) | |
|
<0.05 |
>0.05 | >0.05 | >0.05 | >0.05 | |
|
||||||
Haze (no/epithelial/stromal) (%) | Group A | 37.5/62.5/0 | 30/70/0 | 50/50/0 | 50/28.6/21.4 | 57.1/0/42.9 |
Group B | 6.3/93.8/0 | 20/80/0 | 50/50/0 | 42.9/21.4/35.7 | 71.4/0/28.6 | |
|
>0.05 | >0.05 | >0.05 | >0.05 | >0.05 |
D-Panthenol proved to be of significant value in epithelial regeneration [
In view of the
The first item that captures interest is speed of epithelial defect coverage. This would be the most anticipated point and visible for the examiner at the same time. At this point, D-panthenol showed no difference (Table
Similar to healing rate, both groups showed similar discomfort scores, during epithelial defect (Table
During epithelial defect closure, visual acuity showed no statistically significant difference (
After complete epithelial defect closure, ocular surface still needs few weeks to normalize and “smoothen up.” This corresponds to the
During the second stage, D-panthenol group showed superior values, in term of vision, which were only significant at the 1st week (Table
The results of visual acuity in the 2nd phase could be explained by the measurement of the residual manifest cylinder. During this stage, a residual cylinder will result from the surface irregularity, which depends on the progress of healing. It does not represent a direct outcome of laser ablation and is in constant change in the first few months, after the procedure. In this case, it showed exactly the same outcome of vision, which is superior levels for D-panthenol all through the study, but only significant at the first week (Table
The last point of comparison was corneal clarity, after complete epithelial defect closure. We referred to these points during observation as “haze.” It was observed at 2 levels: epithelium and stroma.
When fully healed and regularized, corneal epithelium is invisible. On the contrary, stromal haze is a well-known clinical situation after surface laser ablation [
In an attempt to review the literature on the effects of D-panthenol on the eye and compare previous results to the current study, a few references were retrieved [
This factor may affect retention time and hence clinical effect. Similarly, concentration differed in some studies (5%) [
In spite of some clinical benefits, observed during the course of the study, a statistical benefit could not be revealed completely. So, it could be concluded that D-panthenol induces little effect on corneal epithelial regeneration, if any. It is not known whether this potential effect would vary according to dose or if a larger sample of patients was included to demonstrate this statistical difference.
The data used to support the findings of this study are available from the corresponding author upon request.
The authors declares that there is no conflicts of interest.