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Doctor Soloway first performed the Scleral Spacing Procedure or SSP in Mexico in February 1999. Since that time he has traveled with patients outside the United States up to three times yearly for surgery. In the United States, Dr. Soloway is the Medical Monitor for all phases of the FDA monitored IDE clinical study on the surgical reversal of presbyopia with Refocus Group's (formerly Presbycorp) scleral expansion implants and the principal investigator at the New York Eye and Ear Infirmary. This surgery is based on the principle that the lens in the eye continues to grow as we age. The lens crowds the focusing muscles that surround it, thereby making them less effective for seeing up close. The goal of this surgery is to expand the space surrounding the lens giving the muscles more room to work and focus. We are using Refocus (formerly PresbyCorp) Group's Presview implant during these trials, the same implant that Dr. Soloway has successfully used on numerous patients treated abroad. During the surgery, these four small arched plastic segments are placed within the white part of the eye.
Fully sponsored FDA Phase II clinical trials have begun in New York with the FDA and New York Eye and Ear Infirmary IRB approvals in December 2003. Refocus Group (formerly Presby Corp) is sponsoring these surgeries and there will be no expense to the patient after they have been found to be appropriate for the surgery Patients selected for this trial will have all medical, surgical and hospital care fees paid for by the sponsor. We are currently recruiting additional patients for these studies. If you think that you fit the criteria below and are interested in participating in one of these studies, please contact us at the number below:
Inclusion Criteria
1) Patients between 50 to 60 years old
2) Best corrected distance vision 20/20
3) Uncorrected near vision less than 20/63
4) Distance SE refraction between -0.50 and +0.75
5) Less than 1.0 diopters of astigmatism
6) Patient still has their natural lens
7) Able to comply with the requirements and restrictions of the
study
Exclusion Criteria
1) Chronic imflammation in the eye
2) Scleral thickness less than 530 microns
3) Any prior eye surgery (including LASIK or other vision correction)
4) Chronic ocular disease
5) Acute ocular disease
6) Chronic systemic disease
We are using Refocus (formerly PresbyCorp) Group's Presview implant during these trials, the same implant that Dr. Soloway has successfully used on numerous patients treated abroad.
If you are interested in this surgery and think you might be eligible for the protocol, please call Vista Alliance Eye Care Associates at 212 758 3838 and ask to speak to one of our Vision Coordinators about SSP surgery.
Or click on the links below for more information. If you are interested in having this surgery, before deciding which option might be better for you, it is important to call with your questions, and to set up an appointment for an evaluation. You can call our office at:
212 758 3838 or 888 821 EYES (888 821 3937)
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