Optimization of the Ocular Surface Prior to Cataract Surgery Using PROKERA

Jeff Wongskhaluang

Status: Completed

Conditions: Cataract Senile; Cataract; Dry Eye; Dry Eye Syndromes

Treatments: Device: PROKERA

Study type: Interventional

Funder types: Other

Identifiers

NCT05148507

9132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Treatment

Experimental group

Description:

Application of cryopreserved amniotic membrane (Prokera)

Treatment:

Device: PROKERA