Optimization of the Ocular Surface Prior to Cataract Surgery Using PROKERA

Completed · Not applicable

Conditions studied: Cataract, Dry Eye Syndromes, Cataract Senile, Dry Eye

In brief

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.

Key facts

Study ID

NCT05148507

Run by

Jeff Wongskhaluang

People needed

43

Starts

2021-11-04

Expected to finish

2025-01-21

Last updated by the study team

2025-03-11

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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.)
• History of clinically significant ocular trauma
• Significant posterior corneal astigmatism (≥ 0.75 D)
• History of herpetic keratitis
• Ongoing ocular or systemic infection
• Visually significant retinal pathology
• Clinically significant findings observed at screening, including lid abnormalities, epithelial basement membrane dystrophy, Salzmann's nodular degeneration, subclinical or clinical keratoconus (defined as KISA% index > 6019), ectasia (Belin/Ambrosio enhanced ectasia display final 'D' index > 2.6920), Fuchs' endothelial corneal dystrophy (Using the Classification by Sun et al21), etc.
• Short eyes (axial length < 22 mm22, 23)
• High myopia (axial length ≥ 26 mm)22, 24
• Eyes with glaucoma drainage devices or filtering bleb
• Patients with a history of drug reactions to Ciprofloxacin, Amphotericin B, Glycerol, and/or DMEM.
• Patient cannot close the eyelid, has an incomplete blink, or demonstrates any other signs of exposure that cannot be addressed by the investigator
• Pregnancy or subject expecting to be pregnant
• Use of additional eye medications (i.e. glaucoma eye drops, anti-histamines, etc)

Where it is running

• Grin Eye Care — Olathe, Kansas, United States

Full record on ClinicalTrials.gov

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