Dry Eye Syndrome
Conditions
Keywords
dry eye, autologous serum, cyclosporine ophthalmic emulsion
Brief summary
The present study aimed to evaluate and compare the efficacy of a 1 month clinical trial of 50% AS for the treatment of severe dry eye syndrom (DES) based on Schirmer's Test, tear break-up time (TBUT), fluorescein staining, and ocular surface disease index (OSDI) scores, as compared to conventional preservative-free artificial tears (PFAT) plus 0.05% COE treatment in patients with severe DES
Detailed description
This is an retrospective comparative study. The designation of the patient whether to use AS 8\*1 or conventional PFAT 8\*1 plus COE 2\*1 was determined randomly. Student's paired samples t-test, independent samples Student's t-test, Wilcoxon signed-rank test and Mann-Whitney U test were used to compare data. All patients responded well to both treatments after the first 1-month treatment period, based on comparison of before and after treatment OSDI scores, Schirmer's test results, TBUT values, and OXFORD scale scores.
Interventions
DRUGCOE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1
clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye
BIOLOGICALAS 50% eye drops 8*1
clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye
Sponsors
Usak State Hospital
Seref istek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants chose their treatment regime randomly
Intervention model description
The comparison of 50 % concentration autologous serum eye drops versus preservative free artificial eye drop plus 0.05 % cyclosporin ophthalmic emulsion in the treatment of severe dry eye syndrom
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* refractory to conventional treatment (those that did not respond well to entire dry eye medications containing hydroxypropyl methylellulose, carboxyl methylcellulose, polyvinyl alcohol, polyethylene glycol-propylene glycol, sodium hyaluronate, mineral oil, dextran, and carbomer artificial tears with or without preservatives) * had low TBUT (\< 5 s) (5μL of fluorescein sodium 2% eye drops was used) * low Schirmer's test I score without topical anesthesia ( basic+reflex secretion), positive corneal and conjunctival fluorescein staining (≥grade 1 according to the OXFORD Scale) (3) and an OSDI score \> 40 OSDI was a reliable and valid test for quantifying the severity of dry eye symptoms
Exclusion criteria
* active ocular infection or any other inflammation not associated with dry eye * a severe associated ocular allergy, eyelid or eyelash abnormality * current contact lens use, history of refractive surgery * associated glaucoma * current use of any type of topical eye drops other than dry eye medications * any known graft-versus host disease * known severe anemia (hemoglobin\<11 g/dL-1) * medically uncontrolled significant cerebrovascular and cardiovascular disease * pregnant and lactating patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| schirmers test 1 result | first month results after two treatment regimes for severe dry eye groupes, 5 minutes tear drop wetness of schirmers paper in milimeters | clinical improvement in schirmer's test 1 result |
| ocular surface oxford scale | first month results after two treatment regimes for severe dry eye groupes, dry eye symptom scale graded 1 to 4 | clinical improvement in oxford scale |
| ocular surface disease index scale (OSDI) | first month results after two treatment regimes for severe dry eye groupes, dry eye symptoms graduation prepared with sample questions concluded in 2 digit numbers from 25 to 100, | clinical improvement in OSDI |
| tear break up time | first month results after two treatment regimes for severe dry eye groupes, dry eye quantitave assesment of tear break up time in seconds graded from 0 sec to 10 seconds 10 the best 0 the worst | clinical improvement in tear break up time |
| fluorescein staining of eye | first month results after two treatment regimes for severe dry eye groupes, graduation of dry eye clinical examination graded from 1 to 4 | clinical improvement in fluorescein staining of eye |
Outcome results
None listed