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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined surgery group | Experimental | In this group, all eligible patients will receive pars plana vitrectomy combined with phacoemulsification 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Best correct visual acuity (BCVA) | BCVA with early treatment diabetic retinopathy study (ETDRS) letters | Change from Baseline at 1 week after the surgery(s) |
| Best correct visual acuity | BCVA with ETDRS letters | Change from Baseline at 1 month after the surgery(s) |
| Best correct visual acuity | BCVA with ETDRS letters | Change from Baseline at 3 months after the surgery(s) |
| Best correct visual acuity | BCVA with ETDRS letters | Change from Baseline at 6 months after the surgery(s) |
| Measure | Description | Time Frame |
|---|---|---|
| VFQ-25 score | Visual Function Questionnaire-25, values from 0-100, the higher scores mean a better outcome | Change from Baseline at 6 months after the surgery(s). |
| Complications | Common complications after the surgery like glaucoma, macular edema, iritis, et. al. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic center, Sun Yat-sen University | Guangzhou | Guangdong | 550000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6521988 | Background | 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. | |
| 11255058 | Background | 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. |
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|
| 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. |
|
| through study completion, an average of 1 year |
| Treatment costs | The amount of money paid on the surgery(s) by each patient. | through study completion, an average of 1 year |
| Working delay time | The working delay time due to the surgery(s). | through study completion, an average of 1 year |
| 9097793 | Background | 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. |
| 9224458 | Background | 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. |
| 3174063 | Background | 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. |
| 3341344 | Background | Soto-Hernandez JL, Nunley D, Gutierrez CC, Berk SL. Listeria monocytogenes peritonitis. Am J Gastroenterol. 1988 Feb;83(2):180-2. |
| 1155546 | Background | 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. |
| 16328429 | Background | 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. |
| 12036644 | Background | 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. |
| 309730 | Background | 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. |
| 3601363 | Background | 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. |
| 8963856 | Background | 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. |
| 24830822 | Background | 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. |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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