Dataset Information

Protocol for a parallel assignment prospective, randomised, comparative trial to evaluate the safety and efficacy of intense pulsed light (IPL) combined with 3% diquafosol (DQS) ophthalmic solution in dry eye syndrome.

ABSTRACT:

Introduction

Evaporative dry eye (EDE) is common and can lead to ocular pain, decreased visual quality and reduced quality of life. Intense pulsed light (IPL) and 3% diquafosol ophthalmic solution have been found to be beneficial in reducing signs and symptoms of dry eye.

Methods and analysis

A randomised clinical trial will be performed at He Eye Specialist Hospital in Shenyang. 360 dry eye disease patients will be equally divided randomly into the IPL group, DQS group (3% diquafosol ophthalmic solution eye-drops) and IPL+group (IPL combined with 3% diquafosol eye-drops). All groups will be followed up for 4 weeks. The primary outcome measures will be the non-invasive tear break-up time and the Ocular Surface Disease Index change from the baseline. The secondary outcome measures willincludeconjunctival and cornea staining with fluorescein and lissamine, meibomian gland function and secretion quality, tear film lipid layer score, tear meniscus height, conjunctival hyperemia (redness score) changes . Adverse events also will be monitored and documented.

Discussion

This study aimed to assess whether the combination of IPL with 3% diquafosol ophthalmic solution (study group), IPL+ (study group), is more effective than IPL (active control group) or DQS (active control group) in participants with EDE.

Ethics and dissemination

Management of dry eye with IPL combined with 3% diquafosol ophthalmic solution, registered on 23 January 2023. Ethics approval number: IRB (2022) K029.01. The study's findings will be shared regardless of the effect's direction.

Trial registration number

NCT05694026.

SUBMITTER: Chen J

PROVIDER: S-EPMC10465902 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Protocol for a parallel assignment prospective, randomised, comparative trial to evaluate the safety and efficacy of intense pulsed light (IPL) combined with 3% diquafosol (DQS) ophthalmic solution in dry eye syndrome.

Chen Jiayan J Qin Guanghao G Li Liangzhe L Qi Yifan Y Che Huixin H Huang He H Xia Yang Y Zhang Qing Q Wu Yi Y Yang Lanting L Moutari Salissou S Moore Jonathan E JE Xu Ling L He Wei W Yu Sile S Pazo Emmanuel Eric EE He Xingru X

BMJ open 20230829 8

<h4>Introduction</h4>Evaporative dry eye (EDE) is common and can lead to ocular pain, decreased visual quality and reduced quality of life. Intense pulsed light (IPL) and 3% diquafosol ophthalmic solution have been found to be beneficial in reducing signs and symptoms of dry eye.<h4>Methods and analysis</h4>A randomised clinical trial will be performed at He Eye Specialist Hospital in Shenyang. 360 dry eye disease patients will be equally divided randomly into the IPL group, DQS group (3% diquaf ...[more]

PMID: 37643847

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Project description:BackgroundIntense pulsed light therapy (IPL) is a recently developed way of treating dry eye disease (DED). During the last decade, there was a multiplication of trials studying IPL efficacy. The goal of this review is to summarize the most important and significant results of these trials estimating effect sizes.MethodsThe PubMed and sciencedirect databases were searched using a PICO model-based approach. Randomized controlled trials including at least 20 patients with DED and no other eye condition, with a control group and break-up time or symptom scores data available for extraction were included in this review. Statistical analysis evaluated the tear break-up time (TBUT), non-invasive break-up time (NIBUT), ocular surface disease index (OSDI), and standard patient evaluation of eye dryness (SPEED). Three comparisons were carried on for each outcome: longest follow-up values vs. baseline in the treatment group, longest follow-up values in the treatment group vs. control group, and changes from baseline in the treatment group vs. control group. A subgroup analysis was carried on.ResultsEleven randomized controlled trials, published between 2015 and 2021 were included in this systematic review with 759 patients in total. The longest follow-up values vs. baseline in the treatment group analyses were significantly in favor of IPL for all the parameters studied for instance: NIBUT (effect size (ES), 2.02; 95% confidence interval (CI), (1.43; 2.62)), TBUT (ES, 1.83; 95% CI, (0.96; 2.69)), OSDI (ES, -1.38; 95% CI, (-2.12; -0.64)) and SPEED (ES, -1.15; 95% CI, (-1.72; -0.57)). The longest follow-up values in the treatment group vs. control group analyses, and, the change from baseline in the treatment group vs. control group analyses, were both significantly in favor of IPL for NIBUT, TBUT, and SPEED but not for OSDI.ConclusionsIPL seems to have a positive effect on tear stability evaluated by the break-up times. However, the effect on DED symptoms is less clear. Some confounding factors such as the age and the IPL device used influence the results indicating that the ideal settings still need to be found and personalized for the patient.

Project description:Vitiligo patients may desire laser hair removal, skin rejuvenation, vascular treatments, and other laser or intense pulsed light (IPL) assisted treatments. However, there is a risk of inducing new depigmented patches (Koebner phenomenon). In absence of guidelines on the safe use of laser or IPL in vitiligo patients, dermatologists tend to be reluctant to administer these treatments. The aim of this survey study was to provide an estimation of the occurrence and related risk factors of laser/IPL-induced leukoderma or vitiligo. A cross-sectional survey study was performed among 15 vitiligo experts from 11 countries, with 14 questions about affected patients, involved laser/IPL treatments and the physicians' approach. In a total of 11,300 vitiligo patients, laser/IPL-induced leukoderma or vitiligo was reported in 30 patients (0.27%). Of these, 12 (40%) patients had a medical history of vitiligo and seven (58%) of these patients had stable (> 12 months) vitiligo before the treatment. Most frequently reported were hair removal procedures and localization of the face and legs. Side effects like blistering, crusting, and erosions occurred in 56.7% of the cases. These vitiligo experts based their advice on the risk of the laser treatment on stability of the vitiligo (43%) and activity signs (50%), and 50% discuss the risks before starting a laser treatment. Relevant activity signs are the Koebner phenomenon (57.1%), confetti-like lesions (57.1%) and hypochromic borders (50%). Laser-induced leukoderma or vitiligo is an uncommon phenomenon. Remarkably, a minority had a medical history of vitiligo of which 58% were stable. Consequently, most cases could not have been prevented by not treating vitiligo patients. However, a majority had laser/IPL-induced skin damage. Therefore, caution is advised with aggressive settings and test-spots prior to the treatment are recommended. This study showed significant variation in the current recommendations and approach of vitiligo experts regarding laser/IPL-induced leukoderma or vitiligo.

Project description:PurposeTo compare the safety and efficacy of intense pulsed light (IPL) followed by meibomian gland expression (MGX), against monotherapy of MGX.MethodsPatients with moderate to severe meibomian gland dysfunction (MGD) were 1:1 randomized to 4 sessions of intense pulse light + MGX at 2-week intervals, or 4 sessions of Sham + MGX at 2-week intervals. Both patients and examiners were blinded to the allocation. Outcome measures, evaluated at the baseline (BL) and at a follow-up (FU) conducted 4 weeks after the last IPL session, included fluorescein tear breakup time (TBUT) as the primary outcome measure, OSDI (Ocular Surface Disease Index) questionnaire, Eye Dryness Score (EDS, a visual analog scale (VAS)-based questionnaire), Meibomian gland score (MGS, a score of meibum expressibility and quality in 15 glands on the lower eyelid), daily use of artificial tears, and daily use of warm compresses. In addition, during each treatment session, the number of expressible glands was counted in both eyelids, the predominant quality of meibum was estimated in both eyelids, and the level of pain/discomfort due to MGX and IPL was recorded.ResultsTBUT increased from 3.8±0.2 (μ±standard error of mean (SEM)) to 4.5±0.3 seconds in the control arm, and from 4.0±0.2 to 6.0±0.3 in the study arm. The difference between arms was statistically significant (P < .01). Other signs/symptoms which improved in both arms but were greater in the study arm included MGS (P < .001), EDS (P < .01), the number of expressible glands in the lower eyelids (P < .0001) and upper eyelid (P < .0001), the predominant meibum quality in the lower eyelid (P < .0001) and upper eyelid (P < .0001), and the level of pain due to MGX (P < .0001). Outcome measures which improved in both arms with no significant differences between the two were OSDI (P = .9984), and the daily use of artificial tears (P = .8216). Meibography, daily use of warm compresses, and severity of skin rosacea did not show statistically significant changes in either arm. No serious adverse events were observed. There was a slight tendency for more adverse events in the control group (P = 0.06).ConclusionsThe results of this study suggest that, in patients with moderate to severe symptoms, combination therapy of intense pulse light (IPL) and meibomian gland expression (MGX) could be a safe and useful approach for improving signs of dry eye disease (DED) due to meibomian gland dysfunction (MGD). Future studies are needed to elucidate if and how such improvements can be generalized to different severity levels of MGD.

Dataset Information

Protocol for a parallel assignment prospective, randomised, comparative trial to evaluate the safety and efficacy of intense pulsed light (IPL) combined with 3% diquafosol (DQS) ophthalmic solution in dry eye syndrome.

Introduction

Methods and analysis

Discussion

Ethics and dissemination

Trial registration number

Publications

Protocol for a parallel assignment prospective, randomised, comparative trial to evaluate the safety and efficacy of intense pulsed light (IPL) combined with 3% diquafosol (DQS) ophthalmic solution in dry eye syndrome.

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