Clinical trial NCT04729023: Pars Plana Vitrectomy Combined With Phacoemulsification Cataract Surgery in Phakic Diabetes Retinopathy Patients
Official title: The Effect of Pars Plana Vitrectomy Combined With Phacoemulsification Cataract Surgery in Phakic Diabetes Retinopathy Patients Over 45 Years Old: a Multicenter Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Diabetic Cataract
Keywords: Diabetic Retinopathy
Diabetic Cataract
Pars plana vitrectomy
Phacoemulsification
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 129
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Best correct visual acuity (BCVA)
timeFrame: Change from Baseline at 1 week after the surgery(s)
measure: Best correct visual acuity
timeFrame: Change from Baseline at 1 month after the surgery(s)
measure: Best correct visual acuity
timeFrame: Change from Baseline at 3 months after the surgery(s)
measure: Best correct visual acuity
timeFrame: Change from Baseline at 6 months after the surgery(s)
Secondary outcomes:
measure: VFQ-25 score
timeFrame: Change from Baseline at 6 months after the surgery(s).
measure: Complications
timeFrame: through study completion, an average of 1 year
measure: Treatment costs
timeFrame: through study completion, an average of 1 year
measure: Working delay time
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
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