CompletedNot Applicable

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

China129 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Best correct visual acuity (BCVA)

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

Best correct visual acuity

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

Best correct visual acuity

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

Best correct visual acuity

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

Trial details

NCT IDNCT04729023

SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-02

View on ClinicalTrials.gov More Diabetic Retinopathy trials

Plain-language summary

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

What they're measuring

Best correct visual acuity (BCVA)

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

Best correct visual acuity

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

Best correct visual acuity

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

Best correct visual acuity

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