Tilt of the Intraocular Lens in Patients Undergoing Combined Phacoemulsification and Vitrectomy With Airtamponade

NCT ID: NCT03372759

Last Updated: 2018-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Epiretinal Membrane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group air

airtamponade

Group Type ACTIVE_COMPARATOR

airtamponade

Intervention Type PROCEDURE

airtamponade is applicated in the study group air

study group saline

saline

Group Type SHAM_COMPARATOR

saline

Intervention Type PROCEDURE

saline is left in the study Group saline

Interventions

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airtamponade

airtamponade is applicated in the study group air

Intervention Type PROCEDURE

saline

saline is left in the study Group saline

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients sheduled for combined phakoemulsification and 23G pars plana vitrectomy
* Minimum Age of 21 years
* written informed consent

Exclusion Criteria

* none
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Head of the department of Ophthalmology, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Findl, Prof

Role: PRINCIPAL_INVESTIGATOR

Vienna Institute for Research in Ocular Surgery

Locations

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VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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til

Identifier Type: -

Identifier Source: org_study_id

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