Evaluation of Retinal Structure With High Resolution Optical Coherence Tomography (OCT)

• Sponsor: Sebastian Wolf (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT00564291
• Collaborator: University of Bern (Other)
• Enrollment: 700
• Locations: 2
• Anticipated Duration (Months): 203
• Patients Per Site: 350
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy

Condition or Disease	Intervention/Treatment	Phase
Macular Edema; CNV	Other: Examination with an OCT device

Detailed Description

Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 700 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Evaluation of Retinal Structure With High Resolution OCT
• Actual Study Start Date: Jan 1, 2007
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
1 Healthy volunteers	Other: Examination with an OCT device
2 CSME secondary to diabetic retinopathy
3 ARMD with CNV before and after therapy	Other: Examination with an OCT device
4 ARMD atrophic	Other: Examination with an OCT device
5 Retinal vein occlusion	Other: Examination with an OCT device
6 retinitis pigmentosa	Other: Examination with an OCT device
7 vitreoretinal proliferation	Other: Examination with an OCT device

Outcome Measures

Primary Outcome Measures

1. Integrity of retinal layers [End of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Macular disease

• Healthy subjects

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dep. Ophthalmology, University Hospital Bern	Bern		Switzerland	3010
2	Klinik und Poliklinik für Augenheilkunde, University Bern	Bern		Switzerland

Sponsors and Collaborators

• Sebastian Wolf
• University of Bern

Investigators

• Principal Investigator: Sebastian Wolf, MD, PhD, University of Bern
• Study Director: Sebastian Wolf, MD PhD, University of Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sebastian Wolf, Director, University Hospital Inselspital, Berne
• ClinicalTrials.gov Identifier: NCT00564291
• Other Study ID Numbers: KEK 044/07
• First Posted: Nov 27, 2007
• Last Update Posted: Oct 5, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Sebastian Wolf, Director, University Hospital Inselspital, Berne: OCT
• Additional relevant MeSH terms: Macular Edema

Study Results

No Results Posted as of Oct 5, 2021