Refractive Surgery Clinical Trial
Official title:
A Randomized Masked (Reading Center), Controlled, Prospective Pivotal Study of the Effectiveness and Safety of the EyeGate Ocular Bandage Gel, a 0.75% Crosslinked Hyaluronic Acid (HA) Applied Topically, Versus a Bandage Contact Lens (BCL) in Accelerating Re-epithelialization of Large Corneal Epithelial Defects in Patients Having Undergone Photorefractive Keratectomy (PRK).
Prospective, randomized, masked (reading center), controlled pivotal study of Ocular Bandage Gel (OBG) vs. a bandage contact lens (BCL) in subjects who have undergone bilateral photorefractive keratectomy (PRK).
This is a prospective, randomized, masked (reading center), controlled pivotal study of
Ocular Bandage Gel (OBG) vs. a Bandage Contact Lens (BCL) in subjects who have undergone
bilateral photorefractive keratectomy (PRK).
Study subjects will be evaluated and, if eligible following PRK, will receive the study
treatment in a 1:1 randomization with both eyes receiving the same treatment.
Sites will capture the time that PRK surgery OU is completed. Sites will enroll eligible
subjects and randomly assign a subject to Treatment Group (OBG) or Control Group (BCL). One
eye will be randomized as the designated "study eye" for statistical purposes.
The reading center will be masked as to the randomization assignments. Both eyes will receive
the same randomized assignment and both eyes of each subject will be evaluated at all
timepoints.
The defect in both eyes of all subjects will be measured starting at Day 2 (48 hours after
PRK). The slit lamp photos are to be collected at 48 hours (±1 hour) from PRK completion in
both eyes.
The BCL in the Control Group eyes will be removed daily starting at Day 2 for slit lamp
photos. Slit lamp measurements, as well as photography of the epithelial defect (without and
with fluorescein), will be taken of both eyes of all subjects. Photos will be evaluated by a
masked reading center.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00565695 -
Evaluation of the Aspheric ReSTOR Intraocular Lens (IOL) After Routine Cataract Extraction
|
N/A | |
| Completed |
NCT05406973 -
Comparison Between the SBK Microkeratome Versus Femtosecond Laser in Flap Creation During LASIK Surgery for Myopia
|
N/A | |
| Active, not recruiting |
NCT05658718 -
Factors Influencing Nocturnal Symptoms After Refractive Surgery.
|
||
| Recruiting |
NCT06448468 -
Analysis of Ocular Surface Microbiota in Dry Eye Patients After Refractive Surgery
|
||
| Withdrawn |
NCT00466908 -
Accuracy of the Pentacam and IOL Master to Calculate the Effective Corneal Power After Corneal Refractive Surgery
|
||
| Completed |
NCT05060094 -
Comparison of Outcomes Between TransPRK and Off-flap Epi-LASIK
|
||
| Completed |
NCT04396990 -
The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study
|
||
| Recruiting |
NCT04281862 -
DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery
|
Phase 4 | |
| Completed |
NCT03791684 -
Accelerated Versus Standard CXL in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty.
|
N/A | |
| Completed |
NCT04684888 -
Femto-flap Versus SBK Flap,Predictability and Variability
|
N/A | |
| Recruiting |
NCT06264804 -
Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery
|
||
| Completed |
NCT03569423 -
Comparison Between TPRK Versus AAPRK in Correction of Myopia
|
N/A | |
| Recruiting |
NCT02614625 -
Spectral-domain Optical Coherence Tomography of the Eye
|
N/A | |
| Completed |
NCT04899258 -
Evaluation of the Effect of Myopic Femtosecond Laser Assisted-LASIK on Anterior Chamber Flare Values and Corneal Endothelial Cells: A Prospective Before-and-After Study
|
N/A | |
| Completed |
NCT00742950 -
Refractive Change Induced by 2.8-mm Corneal Incision
|
N/A | |
| Completed |
NCT03597906 -
Topography Guided LASIK by Different Protocols for Treatment of Astigmatism
|
N/A | |
| Recruiting |
NCT05037370 -
CONTOURA vs WFO Ablation PRK & LASIK
|
N/A |