Diabetic Cataract, Diabetic Retinopathy
Conditions
Keywords
Diabetic Retinopathy, Diabetic Cataract, Pars plana vitrectomy, Phacoemulsification
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.
Interventions
PROCEDUREPars plana vitrectomy combined with cataract surgery.
In the combined surgery group, phakic diabetes retinopathy patients over 45 years old without severe lens opacity will receive pars plana vitrectomy combined with phacoemulsification and intraocular lens (IOL) implantation at the same time.
PROCEDUREPars plana vitrectomy with subsequent cataract surgery.
In the control group, phakic diabetes retinopathy patients over 45 years old without severe lens opacity will first receive pars plana vitrectomy and a subsequent phacoemulsification with IOL implantation will be performed at least 6 month after the PPV.
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Proliferative diabetes retinopathy ; 2. Age over 45 years old; 3. mild-moderate lens opacities(LOCSⅢ : C3N3P3 or below); 4. recognition of at least one alphabet in ETDRS chart.
Exclusion criteria
1. Long-standing retinal detachment (more than three months), macular affected 2. Low Vision or blind on the other eye; 3. Macular degeneration, including age-related macular degeneration and Polypoidal choroidal vasculopathy; 4. Ocular trauma; 5. Glaucoma; 6. Hereditary retinopathy; 7. Severe lens opacities before the surgery (LOCSⅢ : C4N4P4 or above).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 1 month after the surgery(s) | BCVA with ETDRS letters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Treatment costs | through study completion, an average of 1 year | The amount of money paid on the surgery(s) by each patient. |
| Working delay time | through study completion, an average of 1 year | The working delay time due to the surgery(s). |
Countries
China
Outcome results
None listed