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Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule

P

Prim. Prof. Dr. Oliver Findl, MBA

Status

Completed

Conditions

Endothelial Cell Loss, Corneal

Treatments

Procedure: Rhexis protection shield

Study type

Interventional

Funder types

Other

Identifiers

NCT03855293
Rhexis Protection Shield

Details and patient eligibility

About

Cataract surgery is one of the most frequently performed surgical procedures worldwide. Since the introduction of phacoemulsification to remove the cataractous lens, risk and complication rates of cataract surgery decreased significantly.

The phacoemulsification technique utilizes a high-intensity ultrasound energy for the fragmentation and emulsification of the lens. One of the main complications during phacoemulsification, is damaging of the endothelium due to contact with lens fragments of the nucleus following turbulent flow of irrigating solution, resulting in corneal damage, inflammation of the endothelium and corneal edema.

In this study we want to evaluate the effect of the anterior capsule, gained by capsular rhexis, as a corneal shield during phacoemulsification on the corneal endothelium.

Enrollment

70 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Cataract
  • Age 21 and older
  • Written informed consent prior to surgery
  • Moderate to severe nuclear or mixed cataract

Exclusion criteria

  • Corneal pathologies
  • Pregnancy
  • Patients with an increased surgical risk (i.e. patients with pseudoexfoliation syndrome, patients with the potential risk of intra-operative floppy iris syndrome)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Study group
Other group
Description:
rhexis protection shield
Treatment:
Procedure: Rhexis protection shield
Control group
No Intervention group
Description:
regular surgery

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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