NCT03855293

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

February 24, 2019

Last Update Submit

February 24, 2019

Conditions

Endothelial Cell Loss, Corneal

Outcome Measures

Primary Outcomes (1)

  • endothelium cell loss

    Comparison of the lost endothelium cells in both groups

    1 year

Secondary Outcomes (1)

  • central corneal thickness

    1 year

Study Arms (2)

Study group

OTHER

rhexis protection shield

Procedure: Rhexis protection shield

Control group

NO INTERVENTION

regular surgery

Interventions

Rhexis protection shieldPROCEDURE

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

Study group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Corneal Endothelial Cell Loss

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prim. Prof. Dr.

Study Record Dates

First Submitted

February 24, 2019

First Posted

February 26, 2019

Study Start

March 2, 2016

Primary Completion

April 1, 2017

Study Completion

April 5, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02