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

• Sponsor: Vienna Institute for Research in Ocular Surgery (Other)
• Overall Status: Completed
• CT.gov ID: NCT03372759
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Membrane	Procedure: airtamponade; Procedure: saline	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tilt of the Intraocular Lens in Patients Undergoing Combined Phacoemulsification and Vitrectomy With Airtamponade
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: study group air airtamponade	Procedure: airtamponade; airtamponade is applicated in the study group air
Sham Comparator: study group saline saline	Procedure: saline; saline is left in the study Group saline

Outcome Measures

Primary Outcome Measures

1. postoperative tilt of the IOL is measured with purkinjemetry [3 months]

   airtamponade has the potential to leave postoperative tilt of the IOL

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• Minimum Age of 21 years

• written informed consent

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital	Vienna		Austria	1140

Sponsors and Collaborators

• Vienna Institute for Research in Ocular Surgery

Investigators

• Principal Investigator: Oliver Findl, Prof, Vienna Institute for Research in Ocular Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Head of the department of Ophthalmology, principal investigator, Vienna Institute for Research in Ocular Surgery
• ClinicalTrials.gov Identifier: NCT03372759
• Other Study ID Numbers: til
• First Posted: Dec 14, 2017
• Last Update Posted: Mar 5, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Epiretinal Membrane

Study Results

No Results Posted as of Mar 5, 2018