Pars Plana Vitrectomy Combined With Phacoemulsification Cataract Surgery in Phakic Diabetes Retinopathy Patients

Sun Yat-sen University

Status: Completed

Conditions: Diabetic Cataract; Diabetic Retinopathy

Treatments: Procedure: Pars plana vitrectomy combined with cataract surgery.; Procedure: Pars plana vitrectomy with subsequent cataract surgery.

Study type: Interventional

Funder types: Other

Identifiers

NCT04729023

2020KYPJ167

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

Combined surgery group

Experimental group

Description:

In this group, all eligible patients will receive pars plana vitrectomy combined with phacoemulsification cataract surgery.

Treatment:

Procedure: Pars plana vitrectomy combined with cataract surgery.

Subsequent surgery group

Active Comparator group

Description:

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.

Treatment:

Procedure: Pars plana vitrectomy with subsequent cataract surgery.