Optimization of the Ocular Surface Prior to Cataract Surgery Using PROKERA

NCT05148507 | Completed FDA Device

• 1 other identifier: 9132
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract; Dry Eye Syndromes; Cataract Senile; Dry Eye

Outcome Measures

Primary Outcomes (1)

• Percentage to achieve emmetropia

  Defined as spherical equivalent -0.5D to +0.5D and \<1.0D astigmatism before and after treatment

  2-3 months

Study Arms (1)

Treatment

EXPERIMENTAL

Application of cryopreserved amniotic membrane (Prokera)

Device: PROKERA

Interventions

PROKERA DEVICE

Amniotic membrane is the sac that encloses the baby during pregnancy. Amniotic membrane has been used to treat many ocular (eye) diseases and repair ocular surface damage. PROKERA contains amniotic membrane fastened between a ring system and can be worn in the eye like a contact lens. PROKERA is a medical device that was cleared by the United States food and drug administration (FDA) in 2003.

Treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Jeff Wongskhaluang: lead

Study Sites (1)

Grin Eye Care

Olathe, Kansas, 66061, United States

Location

MeSH Terms

Conditions

Cataract; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician, Principal Investigator

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 8, 2021
• Study Start: November 4, 2021
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

US (1)