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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

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3 Study Matches

Intacs for Keratoconus

The US food and Drug Administration (FDA) originally approved INTACS prescription inserts in April 1999 for the correction of low levels of nearsightedness (-1.00 to -3.00 diopters). Additional clinical data have shown that INTACS are safe for the treatment of keratoconus, in July 2004, FDA approved INTACS inserts for the treatment of keratoconus as a Humanitarian Use Device (FDA approval letter attached). The statute and the implementing regulation of FDA (21 CFR 814.124 (aj) require IRB review and approval before a HUD is used.INTACS prescription inserts are composed of two clear segments, each having an arc length of 150°, they are manufactured form a biomedical material called polymethylmethacrylate (PMMA) and are available in three thicknesses. Two INTACS inserts ranging from 0.250mm to 0.350mm may be implanted depending on the orientation of the cone and the amount of myopia and astigmatism to be reduced.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Steven Verity
53988
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02138669
STU 012011-115
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Inclusion Criteria:
Who have experienced a progressive deterioration in their vision, such thot they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; Who are 21 years of age or older; Who have clear central corneas; Who have a corneal thickness of 450 microns or greater at the proposed incision site; Who have corneal transplantation as the only remaining option to improve their functional vision.
Exclusion Criteria:
Who have abnormally thin corneas or who have a corneal thickness of 449 microns or less at the proposed incision site; Patients with collagen vascular, autoimmune or immunodeficiency disease; Pregnant or nursing patients; Presence of ocular conditions, such as recurrent corneal erosion syndrome or corneal dystrophy, that my predispose the patient to future complications; Patients who are taking on or more of following medications: isotretinoin (Accutane); amiodarone HCL (Cordarone).
Device: Intacs
Keratoconus
Cornea, Keratoconus, Steep cornea
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Artisan Aphakia Lens for the Correction of Aphakia in Children

The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Serena Wang
33601
All
2 Years to 21 Years old
Phase 3
This study is also accepting healthy volunteers
NCT01547442
STU 082013-072
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Inclusion Criteria:

• 2 to 21 years of age
• Have a visually significant cataract or need IOL replacement surgery
• Compromised capsular bag prohibiting implantation of standard posterior IOL
• Subject or parent/guardian must be able to comply with visit schedule and study requirements
• Subject's legal representative must be able to sign the Informed Consent
Exclusion Criteria:

• Under 2 years of age
• Unable to meet Postoperative evaluation requirements
• No useful vision or vision potential in fellow eye
• Mentally retarded patients
• History of corneal disease
• Abnormality of the iris or ocular structure
• ACD less than 3.2 mm
• Uncontrolled glaucoma
• IOP > 25 mmHg
• Chronic or recurrent uveitis
• Preexisting macular pathology that may complicate the ability to assess the benefit of this lens
• Retinal detachment or family history
• Retinal disease that may limit visual potential
• Optic nerve disease that may limit visual potential
• Diabetes mellitus
• Pregnant, lactating or plan to become pregnant
Device: Artisan Aphakia Intraocular Lens
Aphakia
aphakia, secondary intraocular lens, congenital cataract, marfan syndrome, pediatric cataract, ectopia lentis, subluxated lens
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Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®

To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).
Call 214-648-5005
studyfinder@utsouthwestern.edu
Mamta Jain
41138
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT01591902
STU 062012-099
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Inclusion criteria: 1. Subject has given written informed consent and is willing to comply with the requirements of the protocol; 2. Subject is an adult man or woman (≥ 18 years old); 3. Subject has laboratory confirmed HIV infection; 4. Subject is receiving ART that has been stable for at least 8 weeks prior to screening; 5. Subject has physical evidence of abdominal lipohypertrophy, as determined by the examining study physician; 6. Subject has T2DM as determined by previous HbA1c ≥ 6.5%, previous fasting plasma glucose
• ≥ 126 mg/dL (7.0 mmol/L), and/or previous 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during oral glucose tolerance testing (OGTT), and/or previous random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) with symptoms of uncontrolled DM;
• if subject has been diagnosed with T2DM and is on glucose lowering medications for greater than 1 year the above glucose parameters do not apply; 7. Subject, at the time of screening, has HbA1c between 6.0% and 12.0%; 8. Subject's diabetes has been treated for at least 1 year by diet alone, individuals who are on a stable dose (at least 3 months) of insulin, an OHA, or a GLP-1 analogue plus insulin to control diabetes are permitted if their HbA1C is below 6.0%. OHA, GLP-1 analogue, or OHA/GLP-1 analogue plus insulin according to current American Diabetes Association (ADA) guidelines, and doses have been stable for at least 3 months; 9. If the subject is using lipid lowering drugs, the dose must be stable for at least 2 months prior to screening; 10. Subject must have an electrocardiogram (ECG) without clinically significant abnormalities within 6 months prior to screening; 11. Pre-menopausal women of childbearing potential are eligible only if they are not pregnant (negative urine pregnancy tests at screening and baseline) or lactating and are using an acceptable form of birth control prior to study entry and for at least 2 months after completing treatment. Acceptable contraception is defined as two barrier methods, or one barrier method with a spermicide, or an intrauterine device, or an oral contraceptive; 12. Women of non-childbearing potential must be post-menopausal (no menses for more than 1 year) or surgically sterile (tubal ligation or hysterectomy); 13. Women over 40 years old must have a negative mammogram within 6 months prior to screening or a mammogram will be taken at screening; 14. Men must have a normal prostate exam and a prostate specific antigen (PSA) Individuals who are on a stable dose (at least 3 months) of insulin, less than or equal to 5 ng/mL within 6 months prior to screening or PSA and, for men 50 years of age or older, a prostate specific antigen will be measured at screening
Exclusion Criteria:
1. Subject has Type 1 DM; 2. Subject has body mass index (BMI) < 18.5 kg.m2; 3. Subject has or has had an opportunistic infection or acquired immune deficiency syndrome (AIDS)-defining illness within 3 months of screening; 4. Subject has or has had a malignancy or, for women, personal or family (first degree relative) history of breast cancer. Exceptions are basal cell carcinoma, in situ carcinoma of the cervix, in situ anal carcinoma, treated and stable cutaneous squamous cell carcinoma. and stable Kaposi's sarcoma; 5. Pre-existing PDR or severe non-PDR (NPDR), defined as an ETDRS level of ≥ 53 in either eye; 6. Subject has or has had cytomegalovirus (CMV) retinitis, toxoplasmosis, or any other ocular infection that would prevent evaluation of DR; 7. Subject has previously been treated for DR (treatments such as laser photocoagulation, intravitreal injection, or vitrectomy); 8. Subject has any of the following illnesses or conditions: 1. hypopituitarism, history of pituitary tumor or pituitary surgery; 2. untreated hypothyroidism; 3. head irradiation or head trauma that has affected the somatotropic axis; 4. uncontrolled hypertension, defined as systolic pressure > 140 mm Hg and diastolic pressure > 90 mm Hg; 5. unstable CV condition, defined as: i. acute MI; ii. unstable angina; iii. decompensated congestive heart failure (CHF, new onset or exacerbation); iv. stroke; v. history of any of the above within 6 months prior to screening; f. hepatic abnormality, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (3 x ULN); g. renal abnormality, defined as serum creatinine > 2 x ULN; h. lipid metabolism abnormality, defined as fasting triglycerides > 1500 mg/dL; i. anemia, defined as hemoglobin ≤ 7 g/dL; 9. Drug or hormone use as follows 1. Men: change in regimen or supraphysiological dose of testosterone within 2 months prior to screening; 2. anabolic steroids, GH, GH secretagogue, GHRF products or analogs (including EGRIFTA®), IGF-1, or IGF binding protein 3 (IGFBP 3) within 6 months prior to screening; 10. Drug or alcohol dependence within 6 months prior to screening; 11. Subject is using or has used anorectics, anorexigenics, or anti-obesity agents within 3 months prior to screening; 12. Subject is pregnant or nursing; 13. Other significant disease that, in the Investigator's opinion, would exclude the subject from the trial; 14. Participation, within 30 days prior to screening, in another clinical trial of an investigational agent that could affect IGF-1 levels; 15. Known hypersensitivity to the study drug treatments.
Drug: Tesamorelin, Drug: Placebo-Control
HIV, Diabetic Retinopathy
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