Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
Conditions
Keywords
Rhegmatogenous retinal detachment, Proliferative vitreoretinopathy, Intravitreal triamcinolone acetonide, TGF-beta, Matrix metalloproteinases, MMP-2, MMP-9, Macrophages, Vitreous biomarkers, Aqueous humor biomarkers
Brief summary
This prospective, randomized, controlled clinical study evaluates the effects of preoperative intravitreal triamcinolone acetonide (TA) on growth factors and inflammatory mediators in patients with rhegmatogenous retinal detachment (RRD) and proliferative vitreoretinopathy (PVR). Participants are assigned to either an intervention group receiving a 2-mg intravitreal injection of TA 5-7 days before vitrectomy or a control group receiving standard surgical treatment. The study evaluates TGF-β2, TGF-β3, MMP-2, and MMP-9 levels in aqueous humor and vitreous, macrophage cell counts and inflammatory activity in vitreous, subretinal fluid optical density assessed by optical coherence tomography, and vessel diameter index assessed by optical coherence tomography angiography after surgery.
Detailed description
Rhegmatogenous retinal detachment (RRD) complicated by proliferative vitreoretinopathy (PVR) is associated with inflammatory and fibrotic processes that may contribute to retinal structural changes and surgical failure. Transforming growth factor beta (TGF-β) and matrix metalloproteinases (MMPs) are among the mediators involved in these processes, while macrophages may contribute to the inflammatory response associated with PVR. This prospective, randomized, controlled clinical study evaluates the effects of preoperative intravitreal triamcinolone acetonide (TA) on growth factors and inflammatory mediators in patients with RRD and PVR. Eligible participants are allocated to receive either a 2-mg intravitreal injection of TA 5-7 days before vitrectomy or standard surgical treatment without preoperative TA. The study evaluates TGF-β2, TGF-β3, MMP-2, and MMP-9 concentrations in aqueous humor and vitreous samples, as well as vitreous macrophage cell counts and inflammatory activity. Subretinal fluid optical density and postoperative vessel diameter index are also evaluated to assess retinal structural and vascular parameters. The study aims to determine whether preoperative intravitreal TA is associated with changes in inflammatory and growth factor profiles, macrophage-related parameters, subretinal fluid optical density, and postoperative vascular parameters in patients with RRD and PVR.
Interventions
PROCEDUREStandard Vitrectomy
Participants underwent standard surgical treatment for rhegmatogenous retinal detachment with proliferative vitreoretinopathy without preoperative intravitreal triamcinolone acetonide.
Triamcinolone acetonide 2 mg was administered by intravitreal injection 5-7 days before vitrectomy.
Sponsors
Anggun Rama Yudantha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Biomarker laboratory assessors and OCT image assessors were blinded to group allocation. The operating surgeon was not masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older with rhegmatogenous retinal detachment (RRD) and proliferative vitreoretinopathy (PVR) grade B or C. * No previous history of rhegmatogenous retinal detachment. * No requirement for surgical intervention other than treatment for RRD. * Willingness to participate in all study procedures and provide written informed consent.
Exclusion criteria
* RRD with vitreous opacity precluding adequate fundus examination. * RRD caused by a giant retinal tear. * History of cataract surgery within the previous 3 months. * RRD associated with other ocular comorbidities. * Systemic disease that precludes vitrectomy. * History of ocular hypertension or glaucoma. * RRD with a cloudy lens requiring cataract surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Aqueous Humor TGF-β2, TGF-β3, MMP-2, and MMP-9 Levels | From before intravitreal triamcinolone acetonide administration to 5-7 days after administration, immediately before vitrectomy. | Change in aqueous humor concentrations of TGF-β2, TGF-β3, MMP-2, and MMP-9 before and after preoperative intravitreal administration of 2 mg triamcinolone acetonide in the intervention group. Biomarker concentrations are measured using a multiplex assay and expressed in pg/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vessel Diameter Index After Vitrectomy | Postoperative weeks 1, 2, and 4 | Vessel diameter index (VDI) is measured using optical coherence tomography angiography (OCTA) after vitrectomy. VDI is calculated by dividing vascular density by vascular length density. VDI is compared between participants who received preoperative intravitreal triamcinolone acetonide and control participants who received standard surgical treatment without preoperative triamcinolone acetonide. |
| Change in Subretinal Fluid Optical Density Following Intravitreal Triamcinolone Acetonide | From before intravitreal triamcinolone acetonide administration to 5-7 days after administration, immediately before vitrectomy. | Change in optical density of subretinal fluid before and after preoperative intravitreal administration of 2 mg triamcinolone acetonide in the intervention group. Optical density is assessed using optical coherence tomography (OCT) images and image analysis. |
| Vitreous TGF-β2, TGF-β3, MMP-2, and MMP-9 Levels | At the time of vitrectomy; 5-7 days after intravitreal triamcinolone acetonide administration in the intervention group. | Concentrations of TGF-β2, TGF-β3, MMP-2, and MMP-9 in vitreous samples collected during vitrectomy, comparing participants who received preoperative intravitreal triamcinolone acetonide with control participants who received standard surgical treatment without preoperative triamcinolone acetonide. Biomarker concentrations are measured using a multiplex assay and expressed in pg/mL. |
| Vitreous Macrophage Count and Inflammatory Activity | At the time of vitrectomy. | Macrophage populations and inflammatory activity in vitreous samples collected during vitrectomy are assessed using flow cytometry. Macrophage populations include total macrophages (CD68⁺), M0 macrophages (CD68⁺CD80-CD206-), M1 macrophages (CD68⁺CD80⁺), and M2 macrophages (CD68⁺CD206⁺). Macrophage inflammatory activity is assessed by the percentage of NF-κB-positive cells (NF-κB, %). Outcomes are compared between participants who received preoperative intravitreal triamcinolone acetonide and control participants who received standard surgical treatment without preoperative intravitreal triamcinolone acetonide. |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORAnggun Rama Yudantha, Sp.M(K)
Cipto Mangunkusumo Hospital / Faculty of Medicine, Universitas Indonesia
Outcome results
None listed