Pars Plana Vitrectomy Combined With Phacoemulsification Cataract Surgery in Phakic Diabetes Retinopathy Patients
- Conditions
- Diabetic RetinopathyDiabetic Cataract
- Interventions
- Procedure: Pars plana vitrectomy combined with cataract surgery.Procedure: Pars plana vitrectomy with subsequent cataract surgery.
- Registration Number
- NCT04729023
- Brief Summary
Pars plana vitrectomy (PPV) is one of the most widely used surgical therapies to proliferative diabetic retinopathy in the world.
However, as a predictable consequence of PPV surgery, postoperative cataract is observed in 79%-95% of phakic diabetes retinopathy patients after PPV in 6-24 months and a subsequent cataract surgery is usually required. While, the subsequent cataract surgeries not only bring additional economy and workload burden, but also increase the surgical risks. Since the two-step surgical approach has its defects, the combination of PPV and phacoemulsification is an ideal surgical option.
This study is a multi-center prospective study, aimed to evaluate the effect of PPV combined with phacoemulsification cataract surgery in phakic diabetes retinopathy patients, and make a comparation between the combined surgery and the two-step surgery in patients without severe lens opacities.
- Detailed Description
The prevalence of diabetes retinopathy is increasing dramatically recent years. Pars plana vitrectomy (PPV) is one of the most widely used surgical therapies to proliferative diabetic retinopathy in the world.
However, as a predictable consequence of PPV surgery, postoperative cataract is observed in 79%-95% of phakic diabetes retinopathy patients after PPV in 6-24 months.Generally, subsequent cataract surgeries are required for the phakic patients within 6-16 months after the PPV surgery to improve visualization. While, the subsequent cataract surgeries not only bring additional economy and workload burden, but also increase the surgical risks because of the deep anterior chamber, zonular dehiscence, and inflammation. Since the two-step surgical approach has its defects, the combination of PPV and phacoemulsification is an ideal surgical option, which is only suggested in patients with severe lens opacities before the PPV surgery so far. For those with mild-moderate lens opacities, the benefits of combined surgery is unknown.
This study is a multi-center prospective study, aimed to evaluate the effect of PPV combined with phacoemulsification cataract surgery in phakic diabetes retinopathy patients, and make a comparation between the combined surgery and the two-step surgery in patients without severe lens opacities.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- Proliferative diabetes retinopathy ;
- Age over 45 years old;
- mild-moderate lens opacities(LOCSⅢ : C3N3P3 or below);
- recognition of at least one alphabet in ETDRS chart.
- Long-standing retinal detachment (more than three months), macular affected
- Low Vision or blind on the other eye;
- Macular degeneration, including age-related macular degeneration and Polypoidal choroidal vasculopathy;
- Ocular trauma;
- Glaucoma;
- Hereditary retinopathy;
- Severe lens opacities before the surgery (LOCSⅢ : C4N4P4 or above).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined surgery group Pars plana vitrectomy combined with cataract surgery. In this group, all eligible patients will receive pars plana vitrectomy combined with phacoemulsification cataract surgery. Subsequent surgery group Pars plana vitrectomy with subsequent cataract surgery. In this group, all eligible patients will receive pars plana vitrectomy first. And a subsequent phacoemulsification will be systematically performed 6 months after the PPV surgery.
- Primary Outcome Measures
Name Time Method Best correct visual acuity (BCVA) Change from Baseline at 1 week after the surgery(s) BCVA with early treatment diabetic retinopathy study (ETDRS) letters
Best correct visual acuity Change from Baseline at 6 months after the surgery(s) BCVA with ETDRS letters
- Secondary Outcome Measures
Name Time Method VFQ-25 score Change from Baseline at 6 months after the surgery(s). Visual Function Questionnaire-25, values from 0-100, the higher scores mean a better outcome
Complications through study completion, an average of 1 year Common complications after the surgery like glaucoma, macular edema, iritis, et. al.
Working delay time through study completion, an average of 1 year The working delay time due to the surgery(s).
Treatment costs through study completion, an average of 1 year The amount of money paid on the surgery(s) by each patient.
Trial Locations
- Locations (1)
Zhongshan Ophthalmic center, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China