A Phase 2 interventional study of PRP autologous in Dry Eye After LASIK-Laser in Situ Keratomileusis, sponsored by Vissum, Instituto Oftalmológico de Alicante. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-12-04.
Sponsored by Vissum, Instituto Oftalmológico de Alicante · Phase 2, Interventional, and Treatment
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).
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.
Exclusion Criteria:
Autologous platelet rich plasma: 1 drop / 6 times a day during 6 weeks
Corneal fluorescein staining (CFS)
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.
Time frame: Before LASIK surgery and after the 6 weeks of treatment
Dry eye symptoms
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.
Time frame: Before LASIK surgery and after the 6 weeks of treatment
Corrected distance visual acuity (CDVA)
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.
Time frame: Before LASIK surgery and after the 6 weeks of treatment
Conjunctival hyperemia
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).
Time frame: Before LASIK surgery and after the 6 weeks of treatment
No study locations are listed for this record.
Plan to share: No
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Vissum, Instituto Oftalmológico de Alicante