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NCT Number: NCT04729023

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

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic center, Sun Yat-sen University

Guangzhou, Guangdong, 550000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Pars plana vitrectomy combined with cataract surgery.

Procedure

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.

Pars plana vitrectomy with subsequent cataract surgery.

Procedure

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.

Primary outcomes

  1. Best correct visual acuity (BCVA)

    Time frame: Change from Baseline at 1 week after the surgery(s)

    BCVA with early treatment diabetic retinopathy study (ETDRS) letters

  2. Best correct visual acuity

    Time frame: Change from Baseline at 1 month after the surgery(s)

    BCVA with ETDRS letters

  3. Best correct visual acuity

    Time frame: Change from Baseline at 3 months after the surgery(s)

    BCVA with ETDRS letters

  4. Best correct visual acuity

    Time frame: Change from Baseline at 6 months after the surgery(s)

    BCVA with ETDRS letters

Secondary outcomes

  1. VFQ-25 score

    Time frame: 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

  2. Complications

    Time frame: through study completion, an average of 1 year

    Common complications after the surgery like glaucoma, macular edema, iritis, et. al.

  3. Treatment costs

    Time frame: through study completion, an average of 1 year

    The amount of money paid on the surgery(s) by each patient.

  4. Working delay time

    Time frame: through study completion, an average of 1 year

    The working delay time due to the surgery(s).

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2021
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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