Authors: Molham A. Elbakary, Osama E. Shalaby, Waleed A. Allam, Ahmed R. Alagorie, Heba M. Shafik
Categories: Original Article, Dry eye disease, intense pulsed light therapy, punctal plugs, quality of life improvement
Source: Oman Journal of Ophthalmology
The purpose of the study was to evaluate the quality of life (QOL) improvement in evaporative dry eye patients after treatment with intense pulsed light (IPL) therapy compared to punctal plug insertion.
A prospective comparative interventional study included 30 patients with moderate-to-severe evaporative dry eye. Patients’ QOL affection before and after treatment was assessed by the Ocular Surface Disease Index (OSDI) questionnaire. Fifteen patients were treated with IPL therapy (Group 1). The other 15 patients were treated with silicone punctal plug insertion (Group 2).
Improvement of patients’ QOL was noticed in all patients of Group 1, with significant improvement of OSDI score from a mean value of 56.9 to 22.9 (P = 0.001). Improvement was noticed in 80% of Group 2 patients (mean OSDI score 53.8 and 31.7, P = 0.017). The tear breakup time (TBUT) in Group 1 significantly improved from a mean of 3.2 s to 5.9 s (P = 0.001), whereas it showed no significant changes in Group 2 (mean TBUT 3.6 s and 3.9 s, P = 0.654). Complications occurred in 13.3% in Group 2, including punctal granuloma and proximal canalicular obstruction. No adverse effects were recorded in Group 1.
IPL therapy had better results with more improvement of patients’ QOL compared to punctal plugs. It also showed a better safety profile with no reported complications.
Keywords: Dry eye disease, intense pulsed light therapy, punctal plugs, quality of life improvement
Dry eye disease (DED) is a disorder of tears and ocular surface which is related to multiple factors. It is a widely spread disorder affecting hundreds of millions around the world.[1] The evaporative form is the most common form of DED, and it is mainly caused by meibomian gland dysfunction (MGD).[2] The usual traditional treatment options for MGD include warm compresses, expression of meibomian glands (MG), anti-inflammatory drugs, and lubricant eye drops.[3,4,5]
In many instances, the traditional treatment is not effective in relieving dry eye symptoms. Non-pharmacological interventions, such as punctal occlusion, are advocated in such patients. Punctal plugs are designed to block the lacrimal drainage by occluding the punctum. It is also believed to help in the preservation of lubricant drops, improving the tear film both quantitatively and qualitatively.[6,7] Intense pulsed light (IPL) therapy is another option that uses non-coherent large wave-length high-intensity light in the range of 500–1200 nm.[8] IPL therapy has been safely and effectively used by many investigators to treat evaporative dry eye due to MGD.[9,10,11]
One of the known aspects of DED is the poor correlation between the diagnostic tests and the severity of patients’ symptoms. Manifestations resulting from moderate-to-severe DED have significant effects on the patient’s quality of life (QOL).[12,13] That is why evaluation of the QOL in DED patients, using different forms of patient questionnaires, is an essential component of DED management.[14]
This study was conducted to evaluate the improvement of patients’ QOL after treatment of moderate-to-severe evaporative DED with IPL therapy compared to silicone punctal plug insertion.
This prospective comparative interventional study included 30 patients with evaporative dry eye secondary to MGD. The study adhered to the principles of the Declaration of Helsinki and was approved by the ethical committee.
After signing informed consents, the patients were subjected to a thorough ophthalmological evaluation
The study included patients older than 18 years, with moderate or severe evaporative DED. All the included patients used the traditional conservative medical treatment for at least 6 months with unsatisfactory outcomes. The traditional treatment lines included warm compresses, eyelid hygiene, anti-inflammatory drugs, and lubricant eye drops.
The patients then were divided into two
All patients were advised to keep using the same lubricant eye drops when necessary. The patients’ comfort with the drops and the required daily dose were recorded.
Within 1 month after completion of the treatment, all patients were evaluated for DED indices, including lid margin and MG changes, TBUT, and ocular surface fluorescein staining. Improvement of patients’ QOL was assessed using the OSDI questionnaire. The data were collected and statistically analyzed.
The study included 21 females (70%) and 9 males (30%), with a mean age of 40.9 ± 11.2 years (range: 24–61 years). Group 1 included ten females (66.7%) and Group 2 included 11 females (73.3%). The mean age was 39.1 ± 9.6 years (range: 24–51 years) and 42.6 ± 12.7 years (range: 24–61 years) in Groups 1 and 2, respectively. No statistically significant differences were detected between both groups in terms of gender and age of the participants [Table 1].
All patients had MGD with severe or moderate evaporative DED. Pretreatment evaluation showed that the TBUT in Group 1 ranged from 2 to 5 s, with a mean of 3.2 ± 0.8 s. In this group, one patient (6.7%) had TBUT of 5 s, which was in the range of moderate affection. All other patients of the group showed severe TBUT affection <5 s (a mean of 3.1 ± 0.7 s). In Group 2, TBUT ranged from 2 to 6 s with a mean of 3.6 ± 1.4 s, with no significant difference between both groups (P = 0.397). In this group, three patients (20%) had moderate affection for the TBUT (average: 5.7 ± 0.6 s). The remaining patients had severe TBUT affection (average: 2.9 ± 0.6 s).
Corneal surface fluorescein staining was detected in 46.7% in Group 1 and in 53.3% in Group 2. All patients in the study were not comfortable with lubricant eye drops and needed to use them at high frequency with difficult compliance [Table 1].
After treatment, TBUT significantly improved to a mean of 5.9 ± 1.4 s (P = 0.001) in Group 1; however, no significant changes were recorded in Group 2 with a mean of 3.9 ± 1.4 s (P = 0.654). In Group 1, the patient with moderate TBUT affection showed improvement to 7 s. The other group patients with severe TBUT affection showed improvement to a mean of 5.8 ± 1.4 s. In Group 2, the patients with moderate TBUT affection showed no change after treatment (average: 5.7 ± 0.6 s). The patients with severe affection of TBUT showed an insignificant change after treatment (average: 3.2 ± 0.9 s).
Corneal surface fluorescein staining was still detected in 26.7% and 40% in Groups 1 and 2, respectively. The frequency of application of lubricating eye drops dropped to a mean of 3.6 ± 2.9 and 5.0 ± 3.3 applications per day in Groups 1 and 2, respectively [Table 1].
The main outcome parameter in this study was the change in patients’ QOL as evaluated by the OSDI questionnaire. The baseline OSDI score in Group 1 ranged from 36.8 to 79.5, with a mean of 56.9 ± 11.1, with severe QOL affection in all patients. In Group 2, the baseline OSDI score ranged from 31.8 to 86.4 (mean of 53.8 ± 18.3), with severe affection in 80% (average: 61.5 ± 16.3) and moderate affection in 20% of the participants in this group (average: 31.6 ± 0.5).
According to the OSDI questionnaire score, the patients’ QOL showed significant improvement in both the groups. In Group 1, all patients had better OSDI scores after treatment with a mean of 22.9 ± 16.4 (P = 0.001). Normal OSDI score values were recorded in 33.3% of patients in this group, mild affection was reported in 40%, moderate affection in 20%, and in 6.7%, the score was reduced but still in the range of severe affection. In Group 2, 20% of patients reported no symptomatic improvement with the same OSDI scores after treatment. The average post-treatment OSDI score in Group 2 was significantly reduced to 31.7 ± 19 (P = 0.017) [Table 2]. Twenty percent of patients had within normal scores, 20% had mild affection, 33.3% had moderate affection, and 26.7% had a score in the range of severe QOL affection. In Group 2, the patients with original baseline moderate affection of OSDI scores showed improvement to a mean of 16.4 ± 13.4 (P = 0.047), whereas patients with severe OSDI affection improved to a mean of 38.2 ± 17.8 (P = 0.016).
One patient (6.7%) in Group 2 developed punctal granuloma after 3 months in the right eye and 5 months in the left eye. A simple excision was performed, and the patient received topical steroid eye drops. Another patient in Group 2 (6.7%) developed proximal canalicular obstruction in one eye. This patient complained of excessive watering in her left eye 1 year after plug insertion. The plug was removed, and lacrimal examination revealed proximal canalicular block. A canalicular recanalization procedure with bicanalicular intubation was performed. After the procedure, the patient was epiphora free and was kept on lubricant eye drops. No complications were encountered in Group 1.
DED is one of the most commonly encountered conditions in ophthalmic practice, with a widely variable range of estimated prevalence ranging from 5% to 50%.[17,18] The incidence of DED is expected to rise annually in the coming years, following situations such as the COVID-19 pandemic with the noticeable increased use of technology and video-displaying units.[19,20,21] Evaporative dry eye, resulting from excessive tear evaporation from the ocular surface secondary to MGD, represents more than 80% of cases of DED.[22]
Beside the traditional pharmacological treatment, many non-pharmacological treatment options have been used for evaporative dry eye. Punctal plug insertion is one of the well-known non-pharmacological interventions for dry eye, which enhances the retention of tears and lubricant eye drops.[23,24] The possibility of the use of IPL therapy to treat evaporative DED was first reported by Toyos et al.[25] They accidentally noticed the improvement of signs and symptoms of MGD and DED in a patient who received IPL treatment for facial rosacea. Since then, many researchers confirmed the safe and effective use of IPL therapy in the treatment of evaporative DED.[10,26,27,28] The actual mechanism of action of IPL in MGD is not fully understood. The IPL energy may result in the obliteration of erythematous blood vessels with a significant reduction of inflammatory mediators’ reservoirs.[29] The heating effect of IPL with a slight rise in eyelid temperature could help in unclogging the MG.[25] The eradication of Demodex and reduction of eyelid microbial load is another possible mechanism.[30,31] The potential modulatory effect of IPL on inflammatory mediators is also another suggested mechanism.[32,33] The use of thermal systems that deliver heat and pressure to the eyelids as LipiFlow and MiBoflo, and lid margin exfoliation known as “microblepharoexfoliation” has also been advocated.[3,34,35,36]
There is increasing evidence that DED has a significant effect on patients’ QOL. DED patients may suffer pain, role limitation, sleep disorders, anxiety, and depression. QOL affection may be comparable to serious illnesses such as renal failure, angina, and disabling fractures.[12,37,38] This, together with the poor correlation between objective DED tests and patients’ symptoms, has made the QOL assessment a crucial component of patients’ evaluation.[13,14,39] That is why QOL improvement was taken as the main measure of treatment outcome in this study. There are two well-known reliable questionnaires that are commonly used to assess QOL in DED the Impact of Dry Eye on Everyday Life (IDEEL) and the OSDI.[40,41] In this study, the OSDI questionnaire was used as it is an available, widely used tool that can be explained to the patient and completed in a reasonable time.
Among the published studies about IPL therapy, a few of them are comparative. To prove its efficacy, some authors compared the effect of IPL therapy in DED to placebo or sham treatment.[42,43,44] Gao et al.[45] compared the anti-inflammatory effect of IPL to a combination of tobramycin-dexamethasone eye drops and warm compresses. To the best of our knowledge, this is the first study to compare IPL therapy to punctal plugs as non-pharmacological interventions for DED management. A significant improvement in patients’ QOL was noticed in all patients treated with IPL, with a reduction of the mean OSDI score from 56.9 ± 11.1 to 22.9 ± 16.4. A similar improvement was found in 80% of punctal plugs patients who showed a reduction in OSDI score from 53.8 ± 18.3 to 31.7 ± 19.
Complications occurred in 13.3% of patients treated with punctal plugs (Group 2) including punctal granuloma and proximal canalicular obstruction. Twenty percent of patients in this group reported no symptomatic improvement. No complications were encountered in Group 1 (IPL therapy group). Toyos et al.[26] reported adverse events in 14% of their patients treated with IPL, which included red spots, conjunctival cyst, cheek swelling, hair loss at the brow and forehead, floaters, and light sensitivity. They mentioned that most of these complications spontaneously resolved within 1 week.
IPL therapy is a safe and effective non-pharmacological treatment option for evaporative DED. Compared to punctal plugs, IPL therapy offers better QOL to DED patients, without any reported complications.
Nil.
There are no conflicts of interest.