Optimization of the Ocular Surface Prior to Cataract Surgery Using PROKERA

NCT ID: NCT05148507

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-04
• Study Completion Date: 2025-01-21

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.

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.

Conditions

Cataract; Dry Eye Syndromes; Cataract Senile; Dry Eye

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Application of cryopreserved amniotic membrane (Prokera)

Group Type: EXPERIMENTAL

PROKERA

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jeff Wongskhaluang

OTHER

Sponsor Role: lead

Responsible Party

Jeff Wongskhaluang

Physician, Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Grin Eye Care

Olathe, Kansas, United States

Countries

United States

Other Identifiers

9132

Identifier Type: -

Identifier Source: org_study_id