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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
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.
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.
Zhongshan Ophthalmic center, Sun Yat-sen University
Guangzhou, Guangdong, China
Best correct visual acuity (BCVA)
BCVA with early treatment diabetic retinopathy study (ETDRS) letters
Time frame: Change from Baseline at 1 week after the surgery(s)
Best correct visual acuity
BCVA with ETDRS letters
Time frame: Change from Baseline at 1 month after the surgery(s)
Best correct visual acuity
BCVA with ETDRS letters
Time frame: Change from Baseline at 3 months after the surgery(s)
Best correct visual acuity
BCVA with ETDRS letters
Time frame: Change from Baseline at 6 months after the surgery(s)
VFQ-25 score
Visual Function Questionnaire-25, values from 0-100, the higher scores mean a better outcome
Time frame: Change from Baseline at 6 months after the surgery(s).
Complications
Common complications after the surgery like glaucoma, macular edema, iritis, et. al.
Time frame: through study completion, an average of 1 year
Treatment costs
The amount of money paid on the surgery(s) by each patient.
Time frame: through study completion, an average of 1 year
Working delay time
The working delay time due to the surgery(s).
Time frame: through study completion, an average of 1 year
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