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

Status Recruiting

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.

Clinical Trial 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 If you fail two treatments of PROKERA device, you will be withdrawn from the study.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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05148507
• Study type: Interventional
• Source: Grin Eye Care
• Contact: Jeff Wongskhaluang, MD
• Phone: 913-829-5511
• Email: jeff.wongs@grineyecare.com
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2021
• Completion date: June 4, 2022