Long-Term IOP Fluctuation and VF Progression After Triple Procedure - Tabular View

Tracking Information

First Received Date ^ICMJE

January 29, 2007

Last Updated Date

January 29, 2007

Start Date ^ICMJE

October 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Long-Term IOP Fluctuation and VF Progression After Triple Procedure

Official Title ^ICMJE

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

Brief 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.

Detailed 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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Natural History, Longitudinal, Defined Population, Retrospective Study

Condition ^ICMJE

Glaucoma
Filtering Surgery
Intraocular Pressure

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

Hong S, Seong GJ, Hong YJ. Long-term intraocular pressure fluctuation and progressive visual field deterioration in patients with glaucoma and low intraocular pressures after a triple procedure. Arch Ophthalmol. 2007 Aug;125(8):1010-3.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Underwent triple procedure
At leas 3 years of follow-up after surgery
IOP <18mmHg at each postoperative visit
A minimum of 5 visual field examinations
A reference visual field defect score of 16 or less
Good reliability indices of visual field

Exclusion Criteria:

Any other significant ocular diseases or intraocular surgical histories,
Diseases that may affect visual field or diabetes

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00428740

Responsible Party

Study ID Numbers ^ICMJE

3-2006-0388

Study Sponsor ^ICMJE

Yonsei University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Gong Je Seong, MD, PhD

Yondgong Severance Hospital, Yonsei University College of Medicine

Information Provided By

Yonsei University

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP