Tilt of the Intraocular Lens in Patients Undergoing Combined Phacoemulsification and Vitrectomy With Airtamponade
Primary Purpose
Epiretinal Membrane
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
airtamponade
saline
Sponsored by
About this trial
This is an interventional treatment trial for Epiretinal Membrane
Eligibility Criteria
Inclusion Criteria:
- patients sheduled for combined phakoemulsification and 23G pars plana vitrectomy
- Minimum Age of 21 years
- written informed consent
Exclusion Criteria:
- none
Sites / Locations
- VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
study group air
study group saline
Arm Description
airtamponade
saline
Outcomes
Primary Outcome Measures
postoperative tilt of the IOL is measured with purkinjemetry
airtamponade has the potential to leave postoperative tilt of the IOL
Secondary Outcome Measures
Full Information
NCT ID
NCT03372759
First Posted
November 8, 2016
Last Updated
March 1, 2018
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT03372759
Brief Title
Tilt of the Intraocular Lens in Patients Undergoing Combined Phacoemulsification and Vitrectomy With Airtamponade
Official Title
Tilt of the Intraocular Lens in Patients Undergoing Combined Phacoemulsification and Vitrectomy With Airtamponade
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of epiretinal membranes. Due to the possibility of vitrectomy induced cataract, in many ophthalmic surgical centers it has become usual to indicate combined phacoemulsification and vitrectomy in case of existing cataract.
Epiretinal membranes (ERM) and pseudomaculaforamen are disorders involving the posterior pole of the eyeball with consecutive vision loss. ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT). Different study groups showed that even intraoperative use of SD-OCT is possible.
Detailed Description
The aim of the study is to document tilt of the intraocular lens in combined phacoemulsification and vitrectomy by photography of purkinjereflexes. During vitrectomy tamonade with air or saline are regarded as equal in substituting the removed vitreous. In case of airtamponade, air will be resolved within several days. As airtamponade induces more anterior movement of the implanted intraocular lens in the superior parts of the lens, tilt can result. Saline doesn´t have any influence on the intraocular lens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group air
Arm Type
Active Comparator
Arm Description
airtamponade
Arm Title
study group saline
Arm Type
Sham Comparator
Arm Description
saline
Intervention Type
Procedure
Intervention Name(s)
airtamponade
Intervention Description
airtamponade is applicated in the study group air
Intervention Type
Procedure
Intervention Name(s)
saline
Intervention Description
saline is left in the study Group saline
Primary Outcome Measure Information:
Title
postoperative tilt of the IOL is measured with purkinjemetry
Description
airtamponade has the potential to leave postoperative tilt of the IOL
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients sheduled for combined phakoemulsification and 23G pars plana vitrectomy
Minimum Age of 21 years
written informed consent
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Prof
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
City
Vienna
ZIP/Postal Code
1140
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Tilt of the Intraocular Lens in Patients Undergoing Combined Phacoemulsification and Vitrectomy With Airtamponade
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