Treatment Trials

5 Clinical Trials for Various Conditions

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COMPLETED
A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
Description

STUDY OBJECTIVE: To evaluate the safety and efficacy of Acuvail 0.45% administered BID for increasing corneal re-epithelialization, decreasing the time to zero pain in post-photorefractive keratectomy (PRK) surgery, and PRK enhancement assessment at 6 months post op CLINICAL HYPOTHESES: Acuvail 0.45% administered twice daily is superior to Systane Ultra lubricant in treating post PRK pain OVERAL STUDY DESIGN: Structure: Single-center, randomized, open label, contralateral (one eye receives Acuvail, one eye Systane Ultra) Treatment Group: Patients will be randomized to the eye that will receive Acuvail 0.45% Assignment: Acuvail 0.45% in one eye, Systane Ultra in contralateral eye Duration: 6.5 months Controls: Systane Ultra preservative-free lubricant Dosage/Dose Regimen: Study medication will be administered to the randomized eye through post op days 1-2 BID Visit Schedule: Screening (baseline), Day 2-30 (Surgery), post surgery Day 1 and each day through corneal re-epithelialization, post surgery months 1, 3, and 6. Number of Patients: 10 (20 eyes) Condition/Disease: patients undergoing bilateral PRK surgery

COMPLETED
Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
Description

The purpose of this study is to evaluate the effect of ProKera on corneal wound healing after photorefractive keratectomy (PRK) in terms of re-epithelialization, pain, adverse effects, visual recovery, refractive accuracy, and corneal clarity.

COMPLETED
Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft
Description

The main aim of the study is to determine the safety and feasibility of a cultivated autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem cell deficiency.

TERMINATED
A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds
Description

As a consequence of damage to multiple organ systems throughout the course of their disease, diabetic patients suffer a number of chronic complications giving rise to increased morbidity, mortality, and health care costs specific to this population. Within the ophthalmic domain, diabetic retinopathy (DR) frequently induces serious visual impairment. Although DR can be addressed surgically, surgery remains a less than ideal intervention within this population with a well-characterized compromised ability to heal. The introduction of a therapeutic agent that could accelerate wound closure and decrease healing time, thereby reducing the risk and incidence of infection and corneal scarring in these susceptible patients, would represent a significant clinical and pharmacoeconomic advance in the treatment of this condition.

Conditions
COMPLETED
GenTeal in Perioperative Treatment of Laser Assisted in Situ Keratomileusis LASIK Patients
Description

GenTeal gel is an artificial tear gel used to lubricate the surface of the eye. This study will evaluate the effect of GenTeal gel on comfort following LASIK surgery. Participants will be asked to come to the clinic for three regularly scheduled visits after LASIK surgery: Day 1 (one day after LASIK surgery), Day 7 (one week follow-up), and Day 30 (one month follow-up). Participants will be asked to complete a questionnaire regarding eye comfort during each follow up visit. Participants will be randomly assigned to one of two groups, one of which will receive Genteal Gel four times a day for five days prior to surgery. The other group will receive no preoperative gel or lubricant, which has been our standard approach for many years.