Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT07162818
Brief Summary:
PVR remains the major cause of surgical failure in RRD repair.1 Prompt surgical management is the standard therapy in RRD repair. However, in many places, vitreoretinal (VR) surgery facilities is limited, such as in Indonesia, where mainly located within referral hospitals. Until recently, there has been no recommended pharmacological therapy before surgery to prevent the formation of PVR in RRD. . Previous studies involving the use of pharmacological agents, such as anti-inflammatory and anti-proliferative agents, have been reported to prevent the development of PVR. Nepafenac 0.1% eye drops is a potent NSAID that has been proven effective in preventing macular edema in cases of post-cataract surgery and diabetic retinopathy. This study aims to compare the levels of vitreous inflammatory biomarkers in RRD following the administration of preoperative nepafenac 0.1%.
The inclusion criteria were patients of the age of 18 years old and above with macula-off RRD, grade A or B PVR, and RRD onset upon examination up to 1 month. The exclusion criteria included RRD patients with media opacification, a history of intraocular surgery in less than 3 months, other eye disease comorbidities (i.e., macular hole, epiretinal membrane), other systemic diseases, and a history of NSAID allergy.
Detailed Description:
Prospective subjects underwent Vital signs, an eye examination, fundus biomicroscopy, fundus photographs, and an Optical Coherent Tomography (OCT) scan of the macula were performed. This initial eye examination determined the degree of PVR before intervention was administered.
If they met the inclusion criteria, potential subjects were recruited and randomized, allocating the subjects to two groups: an intervention group with nepavenac 0.1% eye drops and a control group with Cenfresh® eye drops, administered 5 days before the vitrectomy. The medication labels were removed and replaced with the study labels.
The subjects were then prepared for surgery by undergoing blood tests, an EKG, and consultation with an anesthesiologist in the perioperative clinic of the Department of Anesthesia, RSCM/FKUI. The surgery was performed in the operating room of the Department of Ophthalmology, FKUI/RSCM Kirana, according to a predetermined schedule, which was after the subjects had used the eye drops for 5 days, 3 times daily. Written instructions and a daily checklist to record the medication drop schedule were provided to each subject.
On the day of surgery, a repeat fundus biomicroscopy examination, fundus photographs, and an OCT macular scan were performed to record the degree of PVR before the vitrectomy. Vitreous samples were taken during vitrectomy to assess vitreous biomarker levels.
After vitrectomy, all subjects underwent follow-up examinations on days 1, 7, and 28 to assess the surgical outcome. At each visit, routine examinations were performed, including vital signs, an eye examination, and fundus biomicroscopy. Fundus photographs and OCT scans were performed three times:
On the first visit during recruitment, the second visit on the day of surgery, and the final one on day 28 postoperatively. All examination results were recorded in the outpatient record at each visit.
Study:
NCT07162818
Study Brief:
Protocol Section:
NCT07162818