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Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule

Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule: a Prospective Randomised Double-masked Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03855293
Enrollment
70
Registered
2019-02-26
Start date
2016-03-02
Completion date
2018-04-05
Last updated
2019-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Cell Loss, Corneal

Brief summary

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.

Interventions

PROCEDURERhexis protection shield

In the study group the anterior capsule will be used as a protection shield during pacoemulsifikation and removed after the phacoemulsifikation

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
endothelium cell loss1 yearComparison of the lost endothelium cells in both groups

Secondary

MeasureTime frameDescription
central corneal thickness1 yearComparison of corneal thickness between both groups

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026