Dry Eye After LASIK-Laser in Situ Keratomileusis
Conditions
Keywords
dry eye, PRP, autologous, after LASIK, ocular surface
Brief summary
To evaluate the efficacy of autologous platelet-rich plasma eye drops (E-PRP) for the treatment of chronic ocular surface syndrome (OSS) following laser in situ keratomileusis (LASIK).
Detailed description
Prospective interventional consecutive case series including 156 eyes of 80 patients affected by chronic post-LASIK OSS who were treated with autologous E-PRP 6 times a day as monotherapy for 6 weeks. Assessment after treatment with E-PRP included: dry eye symptoms, change in corrected distance visual acuity (CDVA), corneal fluorescein staining (CFS) and conjunctival hyperemia.
Interventions
BIOLOGICALPRP autologous
Autologous platelet rich plasma: 1 drop / 6 times a day during 6 weeks
Sponsors
Vissum, Instituto Oftalmológico de Alicante
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective interventional non-comparative consecutive case series.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients suffering from moderate to severe dry eye syndrome for 6 months or more after conventional treatments with artificial tears following LASIK. * Tear break-up time (TBUT) between 4 and 9 seconds.
Exclusion criteria
* Ocular pathology needing topical treatments different than dry eye syndrome * Trombocitopeny, associated pathologies to coagulation factors or any state of plaquets antiagregation (AAS and other AINES). * Ocular tumours, corneal distrophies, history of ocular herpes. * Pregnant or nursering women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal fluorescein staining (CFS) | Before LASIK surgery and after the 6 weeks of treatment | Staining using fluorescein will be graded using the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 (see Appendix 2). On this modified scale, the score 0 corresponds to no staining dots and the score 0.5 to three or less staining dots. A CFS grade of 0 represents complete corneal clearing. A negative change from baseline will indicate improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dry eye symptoms | Before LASIK surgery and after the 6 weeks of treatment | The symptoms of ocular discomfort (unrelated to instillation of the study medication), burning/stinging, foreign body sensation, eye dryness, pain, will be assessed for intensity by the study patients using a self-administered VAS ranging from 0% to 100%. The symptoms will be assessed separately for each eye and data from the worst eye will be used for analysis. A decrease in the VAS score from baseline will indicate improvement. |
| Corrected distance visual acuity (CDVA) | Before LASIK surgery and after the 6 weeks of treatment | Best corrected distance visual acuity (BCDVA) will be measured using the LogMar scale. The patient is seated at 3 or 4 m from the EDTRS or modified EDTRS chart, depending on chart size and must try to read all letters first while covering the left eye, then while covering the right eye. |
| Conjunctival hyperemia | Before LASIK surgery and after the 6 weeks of treatment | Biomicroscopy will be performed using a slit lamp. The patient will be seated while being examined grading of the conjunctival hyperemia, according to the following scales: 0 = None (normal). 1. = Mild (a flush reddish color predominantly confined to the palpebral or bulbar conjunctiva). 2. = Moderate (more prominent red color of the palpebral or bulbar conjunctiva). 3. = Severe (definite redness of palpebral or bulbar conjunctiva). |
Outcome results
None listed