Diabetic RetinopathyNCT04729023

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

A study testing Pars plana vitrectomy combined with cataract surgery. and Pars plana vitrectomy with subsequent cataract surgery. in people with Diabetic Retinopathy and Diabetic Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Diabetic Retinopathy, Diabetic Cataract
What is being tested?: Pars plana vitrectomy combined with cataract surgery. and Pars plana vitrectomy with subsequent cataract surgery.
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: 1 siteChina
Study dates: 1 Feb 2021to 5 Sep 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongshan Ophthalmic center, Sun Yat-sen University
Guangzhou, Guangdong, 550000

Other trials in China

About this study

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

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.

Read the 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.

Conditions: Diabetic Retinopathy, Diabetic Cataract
Being tested: Pars plana vitrectomy combined with cataract surgery., Pars plana vitrectomy with subsequent cataract surgery.
Keywords: Diabetic Retinopathy, Diabetic Cataract, Pars plana vitrectomy, Phacoemulsification
Medical subject headings: Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pars plana vitrectomy combined with cataract surgery.Procedure or surgery
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 or surgery
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.

Study groups in NCT04729023
Study group	Role	What they receive
Combined surgery group	Experimental	In this group, all eligible patients will receive pars plana vitrectomy combined with phacoemulsification cataract surgery. Receives: Procedure: Pars plana vitrectomy combined with cataract surgery.
Subsequent surgery group	Active comparator	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. Receives: Procedure: Pars plana vitrectomy with subsequent cataract surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

Best correct visual acuity (BCVA)
BCVA with early treatment diabetic retinopathy study (ETDRS) letters
Measured: Change from Baseline at 1 week after the surgery(s)
Best correct visual acuity
BCVA with ETDRS letters
Measured: Change from Baseline at 1 month after the surgery(s)
Best correct visual acuity
BCVA with ETDRS letters
Measured: Change from Baseline at 3 months after the surgery(s)
Best correct visual acuity
BCVA with ETDRS letters
Measured: Change from Baseline at 6 months after the surgery(s)

Secondary outcomes (4)

VFQ-25 score
Visual Function Questionnaire-25, values from 0-100, the higher scores mean a better outcome
Measured: Change from Baseline at 6 months after the surgery(s).
Complications
Common complications after the surgery like glaucoma, macular edema, iritis, et. al.
Measured: through study completion, an average of 1 year
Treatment costs
The amount of money paid on the surgery(s) by each patient.
Measured: through study completion, an average of 1 year
Working delay time
The working delay time due to the surgery(s).
Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20215 Sep 2022

First posted28 Jan 2021
Study start1 Feb 2021
Primary completion2 Sep 2022
Study completion5 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04729023
Sponsor's protocol ID: 2020KYPJ167
Status last verified: Sep 2022
First submitted: 21 Jan 2021
Last updated: 9 Sep 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Novak MA, Rice TA, Michels RG, Auer C. The crystalline lens after vitrectomy for diabetic retinopathy. Ophthalmology. 1984 Dec;91(12):1480-4. doi: 10.1016/s0161-6420(84)34100-8.
PubMed 6521988
Hsuan JD, Brown NA, Bron AJ, Patel CK, Rosen PH. Posterior subcapsular and nuclear cataract after vitrectomy. J Cataract Refract Surg. 2001 Mar;27(3):437-44. doi: 10.1016/s0886-3350(00)00585-x.
PubMed 11255058
Melberg NS, Thomas MA. Nuclear sclerotic cataract after vitrectomy in patients younger than 50 years of age. Ophthalmology. 1995 Oct;102(10):1466-71. doi: 10.1016/s0161-6420(95)30844-5.
PubMed 9097793
Blodi BA, Paluska SA. Cataract after vitrectomy in young patients. Ophthalmology. 1997 Jul;104(7):1092-5. doi: 10.1016/s0161-6420(97)30180-8.
PubMed 9224458
Westesson PL, Lundh H. Temporomandibular joint disk displacement: arthrographic and tomographic follow-up after 6 months' treatment with disk-repositioning onlays. Oral Surg Oral Med Oral Pathol. 1988 Sep;66(3):271-8. doi: 10.1016/0030-4220(88)90230-7.
PubMed 3174063
Soto-Hernandez JL, Nunley D, Gutierrez CC, Berk SL. Listeria monocytogenes peritonitis. Am J Gastroenterol. 1988 Feb;83(2):180-2.
PubMed 3341344
Peyman GA, Huamonte F, Goldberg MF. Management of cataract in patients undergoing vitrectomy. Am J Ophthalmol. 1975 Jul;80(1):30-6. doi: 10.1016/0002-9394(75)90864-8.
PubMed 1155546
Treumer F, Bunse A, Rudolf M, Roider J. Pars plana vitrectomy, phacoemulsification and intraocular lens implantation. Comparison of clinical complications in a combined versus two-step surgical approach. Graefes Arch Clin Exp Ophthalmol. 2006 Jul;244(7):808-15. doi: 10.1007/s00417-005-0146-9. Epub 2005 Dec 3.
PubMed 16328429
Biro Z, Kovacs B. Results of cataract surgery in previously vitrectomized eyes. J Cataract Refract Surg. 2002 Jun;28(6):1003-6. doi: 10.1016/s0886-3350(02)01237-3.
PubMed 12036644
Meyers SM, Klein R, Chandra S, Myers FL. Unplanned extracapsular cataract extraction in postvitrectomy eyes. Am J Ophthalmol. 1978 Nov;86(5):624-6. doi: 10.1016/0002-9394(78)90179-4.
PubMed 309730
Smiddy WE, Stark WJ, Michels RG, Maumenee AE, Terry AC, Glaser BM. Cataract extraction after vitrectomy. Ophthalmology. 1987 May;94(5):483-7. doi: 10.1016/s0161-6420(87)33420-7.
PubMed 3601363
Senn P, Schipper I, Perren B. Combined pars plana vitrectomy, phacoemulsification, and intraocular lens implantation in the capsular bag: a comparison to vitrectomy and subsequent cataract surgery as a two-step procedure. Ophthalmic Surg Lasers. 1995 Sep-Oct;26(5):420-8.
PubMed 8963856
Silva PS, Diala PA, Hamam RN, Arrigg PG, Shah ST, Murtha TL, Schlossman DK, Cavallerano JD, Sun JK, Aiello LP. Visual outcomes from pars plana vitrectomy versus combined pars plana vitrectomy, phacoemulsification, and intraocular lens implantation in patients with diabetes. Retina. 2014 Oct;34(10):1960-8. doi: 10.1097/IAE.0000000000000171.
PubMed 24830822

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetic Retinopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04729023
Acronym / sponsor ID: 2020KYPJ167
Conditions: Diabetic Retinopathy, Diabetic Cataract
Keywords: Diabetic Retinopathy, Diabetic Cataract, Pars plana vitrectomy, Phacoemulsification
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
Study start: 1 Feb 2021 (actual)
Primary completion: 2 Sep 2022 (actual)
Study completion: 5 Sep 2022 (actual)
First posted: 28 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Pars plana vitrectomy (PPV) is one of the most widely used surgical therapies to proliferative diabetic retinopathy in the world.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Combined surgery group	Experimental	Procedure: Pars plana vitrectomy combined with cataract surgery.In this group, all eligible patients will receive pars plana vitrectomy combined with phacoemulsification cataract surgery.
Subsequent surgery group	Active comparator	Procedure: Pars plana vitrectomy with subsequent cataract surgery.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.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pars plana vitrectomy combined with cataract surgery.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.	Procedure or surgery	Combined surgery group
Pars plana vitrectomy with subsequent cataract surgery.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.	Procedure or surgery	Subsequent surgery group

Primary outcome

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
Best correct visual acuity
Time frame: Change from Baseline at 1 month after the surgery(s)
BCVA with ETDRS letters
Best correct visual acuity
Time frame: Change from Baseline at 3 months after the surgery(s)
BCVA with ETDRS letters
Best correct visual acuity
Time frame: Change from Baseline at 6 months after the surgery(s)
BCVA with ETDRS letters

4 secondary outcomes

VFQ-25 score
Time frame: Change from Baseline at 6 months after the surgery(s).
Complications
Time frame: through study completion, an average of 1 year
Treatment costs
Time frame: through study completion, an average of 1 year
Working delay time
Time frame: through study completion, an average of 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
Background: PubMed 6521988Novak MA, Rice TA, Michels RG, Auer C. The crystalline lens after vitrectomy for diabetic retinopathy. Ophthalmology. 1984 Dec;91(12):1480-4. doi: 10.1016/s0161-6420(84)34100-8.
Background: PubMed 11255058Hsuan JD, Brown NA, Bron AJ, Patel CK, Rosen PH. Posterior subcapsular and nuclear cataract after vitrectomy. J Cataract Refract Surg. 2001 Mar;27(3):437-44. doi: 10.1016/s0886-3350(00)00585-x.
Background: PubMed 9097793Melberg NS, Thomas MA. Nuclear sclerotic cataract after vitrectomy in patients younger than 50 years of age. Ophthalmology. 1995 Oct;102(10):1466-71. doi: 10.1016/s0161-6420(95)30844-5.
Background: PubMed 9224458Blodi BA, Paluska SA. Cataract after vitrectomy in young patients. Ophthalmology. 1997 Jul;104(7):1092-5. doi: 10.1016/s0161-6420(97)30180-8.
Background: PubMed 3174063Westesson PL, Lundh H. Temporomandibular joint disk displacement: arthrographic and tomographic follow-up after 6 months' treatment with disk-repositioning onlays. Oral Surg Oral Med Oral Pathol. 1988 Sep;66(3):271-8. doi: 10.1016/0030-4220(88)90230-7.
Background: PubMed 3341344Soto-Hernandez JL, Nunley D, Gutierrez CC, Berk SL. Listeria monocytogenes peritonitis. Am J Gastroenterol. 1988 Feb;83(2):180-2.
Background: PubMed 1155546Peyman GA, Huamonte F, Goldberg MF. Management of cataract in patients undergoing vitrectomy. Am J Ophthalmol. 1975 Jul;80(1):30-6. doi: 10.1016/0002-9394(75)90864-8.
Background: PubMed 16328429Treumer F, Bunse A, Rudolf M, Roider J. Pars plana vitrectomy, phacoemulsification and intraocular lens implantation. Comparison of clinical complications in a combined versus two-step surgical approach. Graefes Arch Clin Exp Ophthalmol. 2006 Jul;244(7):808-15. doi: 10.1007/s00417-005-0146-9. Epub 2005 Dec 3.
Background: PubMed 12036644Biro Z, Kovacs B. Results of cataract surgery in previously vitrectomized eyes. J Cataract Refract Surg. 2002 Jun;28(6):1003-6. doi: 10.1016/s0886-3350(02)01237-3.
Background: PubMed 309730Meyers SM, Klein R, Chandra S, Myers FL. Unplanned extracapsular cataract extraction in postvitrectomy eyes. Am J Ophthalmol. 1978 Nov;86(5):624-6. doi: 10.1016/0002-9394(78)90179-4.
Background: PubMed 3601363Smiddy WE, Stark WJ, Michels RG, Maumenee AE, Terry AC, Glaser BM. Cataract extraction after vitrectomy. Ophthalmology. 1987 May;94(5):483-7. doi: 10.1016/s0161-6420(87)33420-7.
Background: PubMed 8963856Senn P, Schipper I, Perren B. Combined pars plana vitrectomy, phacoemulsification, and intraocular lens implantation in the capsular bag: a comparison to vitrectomy and subsequent cataract surgery as a two-step procedure. Ophthalmic Surg Lasers. 1995 Sep-Oct;26(5):420-8.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best correct visual acuity (BCVA) (time frame: Change from Baseline at 1 week after the surgery(s)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04729023, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.