Optimization of the Ocular Surface Prior to Cataract Surgery Using PROKERA

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Dry Eye; Dry Eye Syndromes; Cataract Senile
• Intervention / Treatment: Device: PROKERA

Detailed Description

Amniotic membrane has been used to treat many ocular 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.

Cataract surgery is the most common eye surgery done in the United States. Prior to cataract surgery, machines scan the eyes to calculate which implant is needed at the time of cataract surgery. When a patient has dry eyes, the machines may have inaccurate measurements.

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. There will be a maximum of 64 eyes of individuals age 18 and older in the study enrolled at one study site. Each subject will have both eyes evaluated for the study.

Prior to cataract surgery, patients enrolled in the study will have PROKERA device inserted on the surface of the eye. The subject will then come back after about five days to remove the PROKERA device and follow up again in one week and two weeks after the removal of the PROKERA device. During both of the follow up visits, the study doctor will grade symptoms based on a questionnaire, examine eyes, take pictures, and grade the severity of the dry eye disease to determine any changes from the baseline testing.

At the two week visit, cataract surgery will be scheduled, which will be within one to two weeks time. After surgery, a one month postoperative visit will occur, where the same examination procedures are performed as the previous follow up visits.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Olathe, Kansas, United States, 66061
      • Grin Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. ≥ 18 years of age and plan to undergo cataract surgery
2. Prior use of DED/keratitis conservative treatments (artificial tears, ointment, Xiidra®, Restasis, warm compresses, etc.) within 30 days
3. Moderate to severe DED/keratitis (SPEED score ≥ 10)
4. Total cornea fluorescein staining score ≥ 4 (NEI scale)
5. Topographic changes such as irregularity, dropout, and higher order aberrations (HOAs; RMS > 0.4) as determined by the investigator

6. Distorted keratometry mires or inconsistent biometry between 2 consecutive readings (30s apart) as determined by the investigator

   Exclusion Criteria:

7. Use of soft contacts lens, bandage contact lens, or scleral lens within 7 days
8. Ocular surgery within 3 months
9. History of refractive surgery (LASIK, keratectomy, radial keratotomy, etc.)
10. History of clinically significant ocular trauma
11. Significant posterior corneal astigmatism (≥ 0.75 D)
12. History of herpetic keratitis
13. Ongoing ocular or systemic infection
14. Visually significant retinal pathology
15. 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.
16. Short eyes (axial length < 22 mm22, 23)
17. High myopia (axial length ≥ 26 mm)22, 24
18. Eyes with glaucoma drainage devices or filtering bleb
19. Patients with a history of drug reactions to Ciprofloxacin, Amphotericin B, Glycerol, and/or DMEM.
20. Patient cannot close the eyelid, has an incomplete blink, or demonstrates any other signs of exposure that cannot be addressed by the investigator
21. Pregnancy or subject expecting to be pregnant
22. Use of additional eye medications (i.e. glaucoma eye drops, anti-histamines, etc)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment; Application of cryopreserved amniotic membrane (Prokera)

Device: PROKERA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage to achieve emmetropia	Defined as spherical equivalent -0.5D to +0.5D and <1.0D astigmatism before and after treatment	2-3 months

Collaborators and Investigators

• Sponsor: Jeff Wongskhaluang

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): January 21, 2025
• Study Completion (Actual): January 21, 2025

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Lens Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 9132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No