Submacular Surgery Trials (SST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000150
Recruitment Status : Completed
First Posted : September 24, 1999
Last Update Posted : September 17, 2009
Information provided by:
National Eye Institute (NEI)

Brief Summary:

To determine whether surgical removal of subfoveal choroidal neovascularization (CNV) and associated hemorrhage in patients with age-related macular degeneration (AMD), the ocular histoplasmosis syndrome (OHS), or idiopathic CNV stabilizes or improves vision more often than observation.

To determine how surgical removal compared to observation of subfoveal CNV due to AMD, OHS, or idiopathic causes changes the patient's perception of health- and vision-related "quality of life," as measured by telephone interview using the Medical Outcomes Survey Short Form-36 (MOS SF-36) instrument, the Hospital Anxiety and Depression Scale, and the National Eye Institute Visual Function Questionnaire (NEI VFQ-25).

To determine whether randomized trials of surgery are warranted for patients with subfoveal CNV associated with age-related macular degeneration not suitable for laser treatment.

Condition or disease Intervention/treatment Phase
Macular Degeneration Histoplasmosis Procedure: Subfoveal Choroidal Neovascularization Removal Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Submacular Surgery Trials (SST)
Study Start Date : January 1999
Study Completion Date : September 2001

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Group B: Patients with evidence of large hemorrhages from subfoveal neovascular AMD lesions, visual acuity (SST protocol) of 20/100 to light perception, with the area of hemorrhage larger than the area of fluorescein angiographically visible CNV, with any visible CNV less than or equal to 9 MPS disc areas, and ability to return for 4 years of follow-up may be eligible for the Group B (Blood) protocol.

Group N: Patients with new CNV (no prior laser) due to AMD, visual acuity (SST protocol) of 20/100 to 20/800, fluorescein angiographic evidence of subfoveal CNV lesion which is less than or equal to 9 MPS disc areas, and ability to return for 4 years of follow-up may be eligible for the Group N (New CNV) protocol.

Group H: Patients with evidence of CNV due to OHS or idiopathic cause, visual acuity (SST protocol) 20/50 to 20/800, fluorescein angiographic evidence of subfoveal CNV lesion (new or recurrent) which is < 9 MPS disc areas, and ability to return for 4 years of follow-up may be eligible for inclusion in the Group H (Histoplasmosis/Idiopathic CNV) protocol. Exclusion criteria include other ocular diseases compromising vision, history of submacular surgery in the study eye, history of subfoveal laser photocoagulation that extends under the foveal avascular zone, recent intraocular surgery, or previous investigational therapy for CNV.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00000150     History of Changes
Other Study ID Numbers: NEI-52
First Posted: September 24, 1999    Key Record Dates
Last Update Posted: September 17, 2009
Last Verified: September 2009

Keywords provided by National Eye Institute (NEI):
Ocular Histoplasmosis Syndrome
Idiopathic Choroidal Neovascularization

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases