Optimization of the Ocular Surface Prior to Cataract Surgery Using PROKERA (NCT05148507) | Clinical Trial Compass
CompletedNot Applicable
Optimization of the Ocular Surface Prior to Cataract Surgery Using PROKERA
United States43 participantsStarted 2021-11-04
Plain-language summary
The purpose of the study is to assess whether PROKERA can sufficiently stabilize the ocular surface prior to cataract surgery and improve post operative outcomes patients with moderate to severe dry disease.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years of age and plan to undergo cataract surgery
✓. Prior use of DED/keratitis conservative treatments (artificial tears, ointment, Xiidra®, Restasis, warm compresses, etc.) within 30 days
✓. Moderate to severe DED/keratitis (SPEED score ≥ 10)
✓. Total cornea fluorescein staining score ≥ 4 (NEI scale)
✓. Topographic changes such as irregularity, dropout, and higher order aberrations (HOAs; RMS \> 0.4) as determined by the investigator
✓. Distorted keratometry mires or inconsistent biometry between 2 consecutive readings (30s apart) as determined by the investigator
Exclusion criteria
✕. Use of soft contacts lens, bandage contact lens, or scleral lens within 7 days
✕. Ocular surgery within 3 months
✕. History of refractive surgery (LASIK, keratectomy, radial keratotomy, etc.)
✕0. History of clinically significant ocular trauma