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NCT03372759 Clinical Trial

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

Epiretinal Membrane Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03372759
Other study ID # til
Secondary ID
Status Completed
Phase N/A
First received November 8, 2016
Last updated March 1, 2018
Start date December 2015
Est. completion date August 2017

Study information
Verified date March 2018
Source Vienna Institute for Research in Ocular Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date August 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- patients sheduled for combined phakoemulsification and 23G pars plana vitrectomy

- Minimum Age of 21 years

- written informed consent

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• airtamponade
airtamponade is applicated in the study group air
• saline
saline is left in the study Group saline

Locations
Country Name City State
Austria VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna

Sponsors (1)
Lead Sponsor Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative tilt of the IOL is measured with purkinjemetry airtamponade has the potential to leave postoperative tilt of the IOL 3 months
See also
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Terminated NCT01532765 - Randomized Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Removal N/A
Completed NCT01474655 - Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal N/A
Active, not recruiting NCT04120311 - Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole Phase 1
Completed NCT04445142 - Fovea ERM After Fovea-sparing ILM Peeling
Recruiting NCT01701518 - A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes N/A
Completed NCT01627977 - Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy Phase 3
Completed NCT01771939 - Phacoemulsification and 25 Gauge (25G) Vitrectomy Versus Phacoemulsification Only in Idiopathic Epiretinal Membranes N/A
Completed NCT00408720 - Comparison of a Spectral OCT/SLO With the Stratus OCT for Imaging Various Retinal Pathologies N/A
Completed NCT05171621 - Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
Active, not recruiting NCT04306718 - Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study N/A
Recruiting NCT01985490 - Change in Foveal Avascular Zone After Removal of Epiretinal Membrane and Internal Limiting Membrane N/A
Completed NCT01238393 - Treatment of Epiretinal Membranes With Ranibizumab N/A
Terminated NCT00333060 - Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal Phase 2
Completed NCT05287269 - Ocular Coherence Tomography During Cataract Assessment
Recruiting NCT05138315 - Quantification of Metamorphopsia in Patients With Epiretinal Membranes N/A
Recruiting NCT03661593 - Aniseikonia in Epiretinal Membrane Patients N/A
Completed NCT03457584 - Effect of Air-tamponade on Intraretinal Cystoid Changes After Membrane Peeling N/A