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Clinical study of vitrectomy cataract phacoemulsification and intraocular lens implantation combined with posterior capsulotomy in patients with PDR

Clinical study of vitrectomy cataract phacoemulsification and intraocular lens implantation combined with capsule incision in patients with PDR

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071439
Enrollment
Unknown
Registered
2023-05-15
Start date
2023-05-16
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

diabetic retinopathy

Interventions

control group:PPV+P+I
intervention group:PPV+P+I+posterior capsulotomy

Sponsors

Tianjin Medical University Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Age: >=18 years old; 2) PPV with cataract surgery is required for patients diagnosed with proliferative diabetic retinopathy (stage IV to VI diabetic retinopathy according to the International Classification of Diabetic retinopathy) and cataract; 3) Patients with indications of surgery; 4) At least part of the cornea is transparent (or the central area of the cornea is transparent) to ensure fundus examination, visual function examination and OCT examination after vitrectomy; 5) Able and willing to sign informed consent

Exclusion criteria

Exclusion criteria: 1) Unwilling or unable to agree to participate in the study, unable to participate in follow-up on time, unwilling to submit to the randomization process, or unable to return to scheduled protocol visits; 2) Participated in another clinical trial within 3 months; 3) Prior intraocular laser therapy, prior intraocular surgery (including cataract surgery), or planned within the next 6 months; 4) A history of poorly controlled glaucoma (defined as intraocular pressure =25mmHg after treatment with anti-glaucoma drugs); 5) Previously diagnosed with wet AMD, retinal vein obstruction and other neovascular retinopathy; 6) Patients diagnosed with premacular membrane, ischemic optic neuropathy, uveitis and other definite fundus diseases; 7) Patients with previous or current diagnosis of diabetic macular edema (OCT showed CST>=300um and BCVA180/110mmHg. Individuals are eligible if their blood pressure is maintained below 180/110 mmHg with antihypertensive medications; 17) A history of transient ischemic attack, stroke, myocardial infarction, acute congestive heart failure, or other acute cardiac events requiring hospitalization within the past 3 months; 18) For women of childbearing age: Potential study participants will be asked about becoming pregnant, breastfeeding or intending to become pregnant within the next 3 years. Researchers will determine when pregnancy tests are needed.

Design outcomes

Secondary

MeasureTime frame
Best corrected visual acuity ;macular and optic disc thickness;macular and optic disc vessels density;

Primary

MeasureTime frame
posterior capsule opacification incidence rate;

Countries

China

Contacts

Public ContactJuping Liu

Tianjin Medical University Eye Hospital

tydljp@126.com+86 137 5203 3227

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026