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NCT00428740 Clinical Trial

Long-Term IOP Fluctuation and VF Progression After Triple Procedure

Glaucoma Clinical Trial

Official title:
Long-Term Intraocular Pressure Fluctuation and Visual Field Progression in Glaucoma Patients With Low Intraocular Pressure After Triple Procedure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00428740
Other study ID # 3-2006-0388
Secondary ID
Status Completed
Phase N/A
First received January 29, 2007
Last updated January 29, 2007
Start date October 2005
Est. completion date December 2005

Study information
Verified date January 2007
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

Long-term intraocular pressure (IOP) fluctuation may be significantly associated with the progression of glaucomatous visual field loss, even in patients kept always low IOP after triple procedure, an effective approach for patients with coexisting glaucoma and visually significant cataracts.

Description:

Previous studies reported that lowering intraocular pressure (IOP) slowed the advancement of visual field damage in glaucoma patients. However, even if the IOP can been substantially lowered, reduction of mean and peak IOP does not always prevent visual field progression.We believe that the long-term IOP fluctuation may play a significant role in visual field deterioration in those patients.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

1. Underwent triple procedure

2. At leas 3 years of follow-up after surgery

3. IOP <18mmHg at each postoperative visit

4. A minimum of 5 visual field examinations

5. A reference visual field defect score of 16 or less

6. Good reliability indices of visual field

Exclusion Criteria:

1. Any other significant ocular diseases or intraocular surgical histories,

2. Diseases that may affect visual field or diabetes

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Yonsei University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

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