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NCT03452748 Clinical Trial

Fourier Transformed Infrared Spectroscopy in Macular Surgery

Epiretinal Membrane Clinical Trial

Official title:
Fourier Transformed Infrared Spectroscopy in Macular Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03452748
Other study ID # FTIR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date June 1, 2019

Study information
Verified date September 2020
Source Vienna Institute for Research in Ocular Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT).

The aim of the study is to examine ERM and internal limiting membranes (ILM) exzised during routine macular surgery with fourier transformed infrared spectroscopy (FTIR) and compare results to optic coherence tomography (OCT) findings.

Description:

Purpose of the present study is to analyse components of ERM and ILM, giving hints for the origin of cells producing ERM. In contrast to electron microscopy, FTIR spectroscopy does not need any chemical fixation of the membranes and therefore structure of components of ERM and ILM are not changed by fixation.

In total, 20 eyes with idiopathic ERM, 10 eyes with lamellar macular hole, 10 eyes with full thickness macular hole and 10 eyes with diabetic ERM will be examined. To our knowledge there are no previous reports about FTIR spectroscopy of ERM and ILM, therefore the study will be performed as an exploratory pilot study.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Idiopathic ERM, lamellar macular holes, full thickness macular holes, diabetic ERM and the indication for surgery (visual symptoms)

- Age 21 and older

- written informed consent for surgery and participation in the study prior to surgery

Exclusion Criteria: - Macular edema due to other reasons than ERM

- Hereditary macular disorders

- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• FTIR spectroscopy
FTIR spectroscopy examines collagen fibers in the excised membranes

Locations
Country Name City State
Austria Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna 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 collagen occurrence of different types of collagen fibres in the excised membranes 3 months
See also
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Completed NCT01474655 - Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal N/A
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Completed NCT04445142 - Fovea ERM After Fovea-sparing ILM Peeling
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Completed NCT01771939 - Phacoemulsification and 25 Gauge (25G) Vitrectomy Versus Phacoemulsification Only in Idiopathic Epiretinal Membranes N/A
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Completed NCT05171621 - Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
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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