Comparison of Autologous Serum Versus Preservative Free Artificial Tear
1 other identifier
interventional
24
1 country
1
Brief Summary
Dry eye is a significant adverse effect of isotretinoin causing patients to use ophthalmic medications. For this reason, many patients using isotretinoin are referred to ophthalmology clinic because of discomfort symptoms. In the literature, there are studies suggesting superiority of Autologous serum drops regarding effects on ocular surface when compared to artificial tear. In addition, Autologous serum was also used in several corneal pathologies with successful outcomes. No data regarding use in the ocular adverse effects of isotretinoin was found in the literature; however, investigators think that it may be an effective alternative in the treatment of dry eye developed during isotretinoin use due to positive effects on ocular surface, epithelial regeneration and anti-inflammatory effect. Autologous serum can be a choice of ophthalmologists in routine practice by increasing number of comprehensive studies investigating effectiveness, safety and long-terms effects of Autologous serum therapy.In this study, it was aimed to investigate dry eye development in the patients receiving systemic retinoic acid therapy and to compare effectiveness of Autologous serum and Preservative free artificial tear in the patients with dry eye disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 31, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedApril 27, 2016
April 1, 2016
5 months
March 31, 2016
April 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Schirmer Test I in Patients with Dry Eye due to isotretinoin use after autologous serum or preservative free artificial tears treatment
Schirmer Test I is used for Dry Eye evaluation before and after autologous serum or preservative free artificial tears treatment. Schirmer test is used to measure tear secretion. Schirmer strips are used for this test. Wetting of the paper is recorded in millimeter
up to 3 Months monthly measurements were done
Change in Break up Time in Patients with Dry Eye due to isotretinoin use after autologous serum or preservative free artificial tears treatment
fluorescein sodium eye drops was used for measurement of Break up Time. Value of Break up Time for per eye is recorded as seconds
up to 3 Months monthly measurements were done
Change in Ocular surface Disease Index in Patients with Dry Eye due to isotretinoin use after autologous serum or preservative free artificial tears treatment
OSDI score is a reliable and feasible test which is commonly used for dry eye patients to grade either dry eye symptom severity and its effect on vision-related function. In this index, people are asked to indicate whether they experienced any of the symptoms or problems due to drye eye, if so, how often. Every question asked to patients is scored from one to four according to the frequency of symptoms. The scores were collected from all the questions.
up to 3 Months monthly measurements were done
Study Arms (2)
preservative free artificial tear drop
EXPERIMENTALpreservative free artificial tears drop is a drop group declaring different kind of active agent like hydroxypropyl methylcellulose, carboxymethyl cellulose etc commonly used in dry eye treatment. Preservative free artificial tear( carboxymethyl cellulose, hydroxypropyl methylcellulose) was used as four times one drop daily. In our study, we prescribed to patients preservative free artificial tears drop(hydroxypropyl methylcellulose or carboxymethyl cellulose) four times one drop daily.
%40 Autologous serum(AS)
EXPERIMENTALperipheral venous blood (14-20 ml) that drawn from antecubital vein of patients to prepare Autologous Serum. Blood sample was left at room temperature over 2 hours for clotting. Serum was obtained after centrifugation at 4000 revolutions per minute (rpm) for 10 minutes at 4 °C using a Nuve NF1200R. Next, in a laminar flow cabinet under sterile conditions, approximately 10 mL of supernatant was collected and diluted to 40 % with isotonic saline solution. It is recommended for dry eye diseases, too. %40 diluted Autologous Serum used as four times one drop daily.
Interventions
Serum that obtained after centrifugation of blood sample
Preservative free artificial tears is a group naming for drops commonly used for drye disease
Eligibility Criteria
You may qualify if:
- isotretinoin use for any reason
You may not qualify if:
- corneal pathologies such as dry eye illness before isotretinoin treatment
- previous cornea surgery, injury or keratitis
- active ocular infection
- meibomian gland dysfunction
- excessive allergic reaction that may be associated with dry eye
- glaucoma therapy use
- severe anemia
- previously use of PFAT or AS for any reason
- (Hb\<10 g/dL) and elevated hepatic function tests requiring withdrawal of therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Niğde State Hospital
Niğde, Niğde Province, 51100, Turkey (Türkiye)
Related Publications (5)
Oner AF, Ferahbas A, Karakucuk S, Utas S, Karaman B, Kutlugun C et al. Ocular side effects associated with systemic isotretinoin. Cutan Ocul Toxicol. 2005;23:189-195.
BACKGROUNDEgger SF, Huber-Spitzy V, Bohler K, Scholda C. [Isotretinoin administration in treatment of acne vulgaris. A prospective study of the kind and extent of ocular complications]. Ophthalmologe. 1995 Feb;92(1):17-20. German.
PMID: 7719068BACKGROUNDTananuvat N, Daniell M, Sullivan LJ, Yi Q, McKelvie P, McCarty DJ, Taylor HR. Controlled study of the use of autologous serum in dry eye patients. Cornea. 2001 Nov;20(8):802-6. doi: 10.1097/00003226-200111000-00005.
PMID: 11685055BACKGROUNDKojima T, Ishida R, Dogru M, Goto E, Matsumoto Y, Kaido M, Tsubota K. The effect of autologous serum eyedrops in the treatment of severe dry eye disease: a prospective randomized case-control study. Am J Ophthalmol. 2005 Feb;139(2):242-6. doi: 10.1016/j.ajo.2004.08.040.
PMID: 15733983BACKGROUNDUrzua CA, Vasquez DH, Huidobro A, Hernandez H, Alfaro J. Randomized double-blind clinical trial of autologous serum versus artificial tears in dry eye syndrome. Curr Eye Res. 2012 Aug;37(8):684-8. doi: 10.3109/02713683.2012.674609. Epub 2012 Jun 6.
PMID: 22670856BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Uğur Yılmaz, M.D.
Niğde State Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Opthalmologist M.D.
Study Record Dates
First Submitted
March 31, 2016
First Posted
April 27, 2016
Study Start
October 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 27, 2016
Record last verified: 2016-04