proliferative diabetic retinopathy with fibrovascular proliferation
Conditions
Interventions
Intervention group:10k/25G beveled-tip probe (BTP)
Control group:5k/23G flat-tip probe (FTP) (Review)
Sponsors
Shaanxi Eye Hospital, Xi'an People's Hospital (Xi'an Fourth Hospital), Affiliated People's Hospital of Northwest University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. PDR patients with a confirmed diagnosis of type II diabetes mellitus; 2. With progressive fibrovascular proliferation (FVP) affecting or threatening the macula, or FVP affecting retinal vasculature resulting in recurrent vitreous haemorrhage, or with persistent vitreous haemorrhage, or resulting in tractional or (and) rhegmatogenous retinal detachment (B ultrasound or OCT pre-assessment). FVP grade 2~4; 3. The patients should have ability to give informed consent; 4. The data of control group will be matched based on the extent of FVP from the surgery recording of a retrospective cohort 2020/1~2022/10 (over 160 cases) with matching rate > 1:3.
Exclusion criteria
Exclusion criteria: 1. PDR without fibrovascular proliferation, or FVP grade 1 by intraoperative observation; 2. Follow-up period of less than 3 months; 3. The patients who are incapable of postoperative posturing; 4. With history of any previous vitreoretinal surgical procedures(incl. scleral buckling) or penetrating ocular trauma, primary rhegmatogenous retinal detachment; 5. With history of receiving intravitreal injection of any anti-VEGF agent (other than within 1 week preoperatively) or steroids within last 3 months; 6. Hypotony (IOP<6mmHg) at baseline or undergone previous glaucoma surgery, treated with topical IOP-lowering medication at anytime from baseline to the time of surgery, uncontrolled glaucoma, neovascular glaucoma; 7. Significant ocular comorbidities such as uveitis; 8. Pregnant or planning to become pregnant; 9. Considered to be not appropriate candidate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intraoperative bleeding sites under fibrovascular proliferation membranes that need electrocoagulation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective number of instrument exchanges through ports (incl. electrocoagulation tips, probes, forceps, scissors, flute needle, visco dissection cannula);Actual vitrectomy time (incl. core & peripheral PPV, and fibrovascular membrane removal);Postoperative intraocular pressure;Changes of Visual outcome; | — |
Countries
China
Contacts
Public ContactZhang Yanchun
Shaanxi Eye Hospital, Xi'an People's Hospital (Xi'an Fourth Hospital), Affiliated People's Hospital of Northwest University
Outcome results
None listed