Optimization of the Ocular Surface Prior to Cataract Surgery Using PROKERA

Cataract Clinical Trial

Official title:

Optimization of the Ocular Surface Prior to Cataract Surgery Using PROKERA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05148507
• Other study ID #: 9132
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2021
• Est. completion date: June 4, 2022

Study information

• Verified date: November 2021
• Source: Grin Eye Care
• Contact: Jeff Wongskhaluang, MD
• Phone: 913-829-5511
• Email: jeff.wongs[@]grineyecare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 2001.

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 The pro Cara 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 your symptoms based on a questionnaire, examine your eyes, take pictures, and grade the severity of the dry eye disease to determine any changes from the baseline testing.

At your two week visit, you will schedule your cataract surgery, which will be within one to two weeks time. If you continue to have dry eye disease after her PROKERA device removal, and your study doctor determines you are not eligible for cataract surgery, you will have another PROKERA device inserted. If you fail two treatments of PROKERA device, you will be withdrawn from the study.

After you undergo surgery, you will need to return for one last follow up visit at one month postoperatively, where you will undergo the same examination procedures as the previous follow up visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 4, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cataract
• Cataract Senile
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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 2001. PROKERA is considering it investigational for the study

Locations

Country	Name	City	State
United States	Grin Eye Care	Olathe	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Jeff Wongskhaluang

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of the final intra-ocular lens power chosen for cataract surgery	Percentage of patients to achieve emmetropia (spherical equivalent -0.5D to +0.5D and <1.0D astigmatism) before and after treatment	2-3 months