Comparison of Restoration in Vitreous Hemorrhage Patients With DME After or Not Removing Inner Limiting Membrane

Comparative Study of Anti-VEGF Effect and Visual Function in Vitreous Hemorrhage Patients With Diabetic Macular Edema After Pars Plana Vitrectomy With Inner Limiting Membrane Peeling or Not

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05529589

Enrollment

120

Registered

2022-09-07

Start date

2023-02-10

Completion date

2023-10-30

Last updated

2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema Due to Diabetes Mellitus, Vitreous Hemorrhage

Brief summary

This study is conducted to compare the anti-VEGF effect and visual function in vitreous hemorrhage patients with diabetic macular edema after pars plana vitrectomy with inner limiting membrane peeling or not

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients with vitreous hemorrhage with diabetic macular edema and require vitreous surgery

Exclusion criteria

1. The patient's preoperative vitreous hemorrhage resulted in the failure of OCT to scan the macular region 2. The patient with a history of anti-VEGF therapy 3. Patients with DME in the contralateral eye requiring anti-VEGF therapy 4. Patients with contraindications of vitreous cavity resection 5. The patient has a history of intraocular surgery 6. The patient has active inflammatory disease 7. The patient has other retinal diseases that affect vision 8. The patient has other systemic diseases that required treatment with anti-VEGF drugs 9. Patient with contraindications to anti-VEGF therapy

Design outcomes

Primary

Measure	Time frame	Description
Thickness change of retinal macular area	12 months	measurement of thickness of retinal macular area with macular optical coherence tomography after operation (0 day, 1 week, 1 months, 3 months, 6 months, 12 months)
Change of visual acuity	12 months	measurement of distance visual acuity with subjective refraction after operation (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)

Secondary

Measure	Time frame	Description
Change of eye pressure	12 months	Measurement of contact tonometry with iCare TA01i tonometer after operation (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)
B-mode ultrasound imaging	12 months	Existing or not of abnormal anatomical structure in posterior eye segment (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)

Countries

China

Contacts

Primary ContactJian Ma, Doctor

jian_ma@zju.edu.cn18858299889

Outcome results