Autologous serum compared to artificial tears for the treatment of dry eye disease

IntroductionPatients with severe dry eye disease (DED) often have limited treatment options with standard non-surgical management focused on the use of artificial tears for lubrication and anti-inflammatory drugs. However, artificial tears do not address the extraordinary complexity of human tears. Crudely, human tears with its vast constituents is essentially filtered blood. Blood and several blood-derived products including autologous serum, have been studied as tear substitutes. This study proposes to test the use of whole, fresh, autologous blood obtained from a finger prick for treatment of severe DED.Methods and analysisThe research team at the two participating sites will approach patients with severe DED for this study. Recruitment will take place over 12 months and we expect to recruit 60 patients in total. The primary outcome of this feasibility study is to estimate the proportion of eligible patients approached who consent to and comply with study procedures including treatment regimen and completion of required questionnaires. The secondary outcome measures, although not powered for in this feasibility, include corneal inflammation (assessed by the Oxford corneal staining guide), patient pain and symptoms scores (assessed by the Ocular Surface Disease Index Score), and objective signs of DED as indicated by visual acuity (assessed by Schirmer’s test, tear break-up time, lower and/or upper tear meniscus height measurement). Other secondary outcomes include patients’ quality of life (assessed using the validated EQ-5D-5L Questionnaire), cost to the National Health Service (NHS) and patient (assessed via use of NHS services and privately purchased over-the-counter treatment related to DED) and safety measure of pressure within the eye (assessed by the Intraocular Pressure (IOP) Score).Ethics and disseminationThis protocol and any subsequent amendments, along with any accompanying material provided to the participant in addition to any advertising material used in this trial have been approved by the East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (REC reference: 17/EE/0508). Written approval from the committee was obtained and subsequently submitted to the respective Trust’s Research and Development (R&D) office with final NHS R&D approval obtained. Data obtained from this study will be published in a suitable peer-review journal and will also presented at international ophthalmic conferences including the American Academy of Ophthalmology, the Royal College of Ophthalmology Annual Congress, the Association for Research and Vision and Ophthalmology, and the European Society of Cataract and Refractive Surgery. Information will be provided to patient groups and charities such as the Sjogren’s Society and the Royal National Institute of Blind People. This will also be shared with the study participants as well as with relevant patient groups and charities.Trial registration numberNCT03395431; Pre-results.

Download Full-text

Comparison of treatment efficacy between 100% platelet-rich plasma and 100% serum eye drops in moderate-to-severe dry eye disease: a randomised controlled trial protocol

BMJ Open ◽

10.1136/bmjopen-2020-048479 ◽

2021 ◽

Vol 11 (6) ◽

pp. e048479

Author(s):

Passara Jongkhajornpong ◽

Pawin Numthavaj ◽

Thunyarat Anothaisintawee ◽

Kaevalin Lekhanont ◽

Gareth McKay ◽

...

Keyword(s):

Dry Eye ◽

Ocular Surface ◽

Platelet Rich Plasma ◽

Controlled Trial ◽

Dry Eye Disease ◽

Autologous Serum ◽

Eye Disease ◽

Eye Drops ◽

Department Of Ophthalmology ◽

Autologous Platelet

IntroductionDry eye disease (DED) is a common eye problem. Although the disease is not fatal, it substantially reduces quality of life and creates a high economic burden, especially in patients with moderate-to-severe DED. Several biological tear substitutes (eg, autologous serum (AS), autologous platelet-rich plasma (APRP) and autologous platelet lysate) could effectively improve dry eyes. However, evidence on their comparative efficacy is controversial. This study aims to compare the efficacy of 100% APRP with 100% AS eye drops in patients with moderate-to-severe DED.Methods and analysisThe study is a single-centre, double-blinded randomised, parallel, non-inferiority trial. One hundred and thirty patients with moderate-to-severe DED, aged 18–70 years will be recruited from outpatient clinic, Department of Ophthalmology, Ramathibodi Hospital, Bangkok from February 2021 to January 2023. Patients will be randomised to receive either 100% APRP or 100% AS eye drops (1:1 ratio) for 4 weeks. The primary outcomes are ocular surface disease index (OSDI) and ocular surface staining (OSS) evaluated using the Oxford scale. Secondary outcomes are fluorescein break-up time, Schirmer’s I test, meibomian gland parameters and adverse events. Other measured outcomes include best-corrected visual acuity, intraocular pressure and compliance.Ethics and disseminationThe study protocol and any supplements used in conducting this trial have been approved by the Ethics Committee of Faculty of Medicine, Ramathibodi Hospital, Mahidol University (MURA2020/1930). Informed consent will be obtained from all patients before study entry. Results will be presented in peer-reviewed journals and international conferences.Trial registration numberNCT04683796.

Download Full-text

Lágrimas artificiais no tratamento da doença do olho seco: uma revisão de literatura/ Artificial tears in the treatment of dry eye disease: a literature review

Brazilian Journal of Development ◽

10.34117/bjdv7n7-024 ◽

2021 ◽

Vol 7 (7) ◽

pp. 65512-65533

Author(s):

Rafaela Montenegro Aires Sampaio ◽

Anyssa Brilhante Aires Montenegro ◽

Claudia Roberta de Andrade

Keyword(s):

Literature Review ◽

Dry Eye ◽

Dry Eye Disease ◽

Eye Disease ◽

Artificial Tears

Download Full-text

The Effect of Autologous Serum Eye Drops in the Treatment of Severe Dry Eye Disease: A Prospective Randomized Case-Control Study

American Journal of Ophthalmology ◽

10.1016/j.ajo.2005.03.067 ◽

2005 ◽

Vol 140 (3) ◽

pp. 565 ◽

Cited By ~ 29

Author(s):

Sandra M. Brown ◽

Jay C. Bradley

Keyword(s):

Dry Eye ◽

Case Control Study ◽

Case Control ◽

Dry Eye Disease ◽

Autologous Serum ◽

Eye Disease ◽

Eye Drops ◽

Control Study ◽

Serum Eye Drops

Download Full-text

Efficacy and safety of two new formulations of artificial tears in subjects with dry eye disease: a 3-month, multicenter, active-controlled, randomized trial

Clinical Ophthalmology ◽

10.2147/opth.s78184 ◽

2015 ◽

pp. 665 ◽

Cited By ~ 25

Author(s):

Peter Simmons ◽

Haixia Liu ◽

Cindy Carlisle-Wilcox ◽

Joseph Vehige

Keyword(s):

Randomized Trial ◽

Dry Eye ◽

Dry Eye Disease ◽

Eye Disease ◽

Efficacy And Safety ◽

Artificial Tears

Download Full-text

Acupuncture at a Single Acupoint, BL1 (Jingming), Compared to Artificial Tears in Moderate to Severe Dry Eye Disease: A Randomized Controlled Trial

10.21203/rs.3.rs-564123/v1 ◽

2021 ◽

Author(s):

xue zhang ◽

Bo Zhang ◽

Siyang Peng ◽

Guoliang Zhang ◽

Jumei Ma ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Dry Eye ◽

Primary Outcome ◽

Controlled Trial ◽

Dry Eye Disease ◽

Eye Disease ◽

Artificial Tears ◽

Artificial Tear ◽

Randomized Controlled

Abstract BackgroundThe global incidence of dry eye disease (DED) is very high. DED seriously affects the quality of life of patients; however, the current curative effect of medicine for moderate to severe DED is poor. This randomized clinical trial was planned to investigate the effect of acupuncture compared with artificial tears on moderate to severe DED.MethodsA randomized clinical trial was performed at 2 hospitals in China. 120 DED patients were randomly equally divided into an acupuncture and an artificial tear group. Either acupuncture or artificial tears was performed for an 8-week period, and a 32-week follow-up was performed. The primary outcome measure was the Schirmer-I test (SIT) value. The secondary outcome measures included the numerical rating scale (NRS) for improvement in ocular symptoms, the ocular surface disease index (OSDI), the tear-film break-up time (TBUT), corneal fluorescein staining (CFS), and acupuncture acceptability. Adverse events also were monitored and documented.ResultsFor the primary outcome, the mean changes in the SIT values were significantly different between the acupuncture (5.75 [2.53‒9.75]) and artificial tear (0.52 [-1.18‒2.46]) groups at week 8 (P = 0.01). The OSDI decreased by -16.14 (-35.40‒16.30) and − 7.65 (-19.25‒15.05) from baseline to week 8 in the acupuncture and artificial tear groups, respectively (P < 0.05). A significant decrease was found in the NRS score for eye dryness, eye pain, and blurred vision in the acupuncture group, as compared to the artificial tear group. However, the change in the average symptom NRS score, TBUT, and CFS did not differ significantly at week 8. Five cases experienced acupuncture-related adverse events.ConclusionsThis randomized clinical trial found that acupuncture at a single acupoint, BL1, significantly promoted tear secretion and improved multiple eye discomfort symptoms. Acupuncture showed greater benefits than artificial tears for moderate to severe DED. However, the study findings warrant verification.Trial registrationRegistration number: ChiCTR1800015831. Name of trial registry: Efficacy and safety of acupuncture in the treatment of moderate to severe dry eye disease: a randomized controlled trial.

Download Full-text

The effect of tamarind seed polysaccharidecontaining eye drop in dry eye syndrome: Results of an interventional, comparative, clinical study

Medical Hypothesis, Discovery & Innovation in Optometry ◽

10.51329/mehdioptometry128 ◽

2021 ◽

Vol 2 (2) ◽

pp. 71-76

Author(s):

Naser Nozari ◽

Shahrokh Ramin

Keyword(s):

Dry Eye ◽

Ocular Surface ◽

Dry Eye Disease ◽

Ocular Surface Disease ◽

Eye Disease ◽

Eye Drops ◽

Artificial Tears ◽

Mean Values ◽

The Mean ◽

Contralateral Eye

Background: The mainstay of dry eye treatment is artificial tear solutions. Contralateral eye comparison of 2 types of artificial tears (Xiloial versus Tearlose) in managing dry eye disease was sought in this study. Methods: This study was a prospective, interventional, contralateral eye comparison of 2 types of artificial tears used for managing dry eye disease. The study participants were categorized into mild (13–22 points), moderate (23–32 points), or severe (33–100 points) ocular surface disease according to the baseline ocular surface disease index (OSDI) questionnaire score. Schirmer I and tear film break-up time (TBUT) tests, as well as detailed slit-lamp examinations, were performed at baseline and at the end of the study. All participants received Xiloial monodose eye drops for the right eye and Tearlose eye drops for the left eye, administered as a single drop 4 times per day. Furthermore, they were instructed to perform lid hygiene every 12 hours per day for both eyes. Results: Thirty-five patients (70 eyes) with a mean ± standard (SD) age of 50.2 ± 13.4 years were included, and 14 (40%) were men. The mean ± SD of the OSDI score was 44.24 ± 22.59 at baseline. Of the 35 patients, 10 (28.6%), 5 (14.3%), and 20 (57.1%) had mild, moderate, and severe ocular surface disease, respectively, according to the baseline OSDI score. Compared to baseline, the mean values of both TBUT and Schirmer I tests improved significantly in both groups (both P < 0.001). In comparing the final mean values between the 2 groups, this improvement was comparable for the Schirmer I test (P = 0.179), but TBUT in Tearlose-instilled eyes improved significantly more than in the fellow eyes (P < 0.001). Conclusions: Both Xiloial and Tearlose eye drops improved tear stability and tear production after a 2 week treatment period in eyes with dry eye disease. This improvement was comparable for tear production, but Tearlose-instilled eyes showed significantly greater improvement in tear stability. Further studies with longer follow-up and larger sample sizes could provide more reliable results as a basis for the clinical use of this TSP-containing lubricant eye drop solution in dry eye disease.

Download Full-text