An Improved Retinal Detachment Repair Method: A First-in-human Clinical Trial of the Safety and Performance of the iSeelr™ Retinal Detachment Repair System to Seal Retinal Tears Intraoperatively
This study is a first-in-human clinical trial testing a new treatment for rhegmatogenous retinal detachments. The new treatment called retinal thermofusion uses a special laser device called iSeelr™ during surgery. The benefit of the device is that it repairs retinal tears without needing a gas bubble making it quicker to recover from surgery. The study will help us determine how safe and well the device performs in repairing a retinal detachment in people.
• Aged 50 years or older.
• Willing and able to comply with all study requirements and visits.
• Provided written informed consent.
⁃ Study Eye:
• Recent onset as demonstrated by symptoms or diagnosis macular involving rhegmatogenous retinal detachment.
• Detachment due to single or multiple retinal tears in the superior 4 clock hours
⁃ Fellow eye:
⁃ • Visual acuity of 6/12 or better.