The Impact of Baseline Diabetic Nephropathy and Preoperative Glycemic Control on the Incidence of Pseudophakic Macular Edema Following Phacoemulsification A Retrospective Cohort Study With ROC-Optimized HbA1c Threshold Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 428
- 试验地点
- 1
- 主要终点
- Incidence of pseudophakic macular edema (PME)
研究概览
简要总结
This retrospective cohort study examines whether the kidney complications of diabetes (diabetic nephropathy) and blood-sugar control before surgery help predict swelling of the central retina, called pseudophakic macular edema (PME), after cataract surgery in people with type 2 diabetes.
PME is a common cause of blurred vision after otherwise successful cataract surgery, and people with diabetes are at higher risk. Doctors currently estimate this risk mainly from the HbA1c blood-sugar level and the stage of diabetic eye disease (retinopathy). It is not yet known whether diabetic kidney disease, measured by the urine albumin-to-creatinine ratio (UACR) and estimated kidney function (eGFR), adds independent information about who will develop PME.
Using medical records already collected during routine care at Thammasat University Hospital, the investigators will measure central retinal thickness on optical coherence tomography (OCT) scans before uncomplicated phacoemulsification cataract surgery with a lens implant, and again 1 and 3 months afterward. PME is defined as at least a 30% increase in central macular thickness. Patients with and without baseline diabetic nephropathy will be compared, and statistical modeling will identify the best preoperative HbA1c threshold for predicting PME.
The results are intended to improve preoperative risk counseling and to help identify diabetic patients who may need closer monitoring after cataract surgery. Because only existing records are used, the study involves no additional visits, tests, or risks for patients.
详细描述
Background and rationale:
Pseudophakic macular edema (PME) is a leading cause of suboptimal visual recovery after otherwise uncomplicated cataract surgery, and diabetes mellitus is an established risk factor. Preoperative risk assessment currently relies mainly on glycemic control (HbA1c) and diabetic retinopathy stage. Diabetic nephropathy and diabetic retinopathy share a common microvascular pathophysiology, yet it has not been established whether baseline diabetic nephropathy carries information about PME risk independently of retinopathy stage and HbA1c. The HbA1c threshold of 7% widely cited in clinical practice also derives from receiver operating characteristic analysis that was not stratified by renal status.
Objectives:
The study tests whether preoperative HbA1c and baseline diabetic nephropathy severity are independent predictors of PME after uncomplicated phacoemulsification in patients with type 2 diabetes, and derives an optimized preoperative HbA1c cut-point for PME prediction, stratified by nephropathy status.
Setting and data sources:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus at the time of surgery
- •Aged ≥18 years
- •Underwent uncomplicated phacoemulsification with posterior-chamber IOL implantation at TUH during the study period
- •Preoperative HbA1c documented within 3 months before surgery
- •Preoperative renal function within 6 months before surgery: serum creatinine (for CKD-EPI 2021 eGFR) and/or spot urine albumin-creatinine ratio (UACR)
- •Baseline spectral-domain macular OCT within 1 month before surgery
- •Postoperative OCT available at both 1 month and 3 months after surgery
- •Minimum 3 months of postoperative follow-up documented
排除标准
- •Pre-existing macular disease (age-related macular degeneration, epiretinal membrane, macular hole, central serous chorioretinopathy, or clinically significant diabetic macular edema at the time of surgery)
- •Intraoperative complication (posterior-capsule rupture, vitreous loss, zonulolysis, or dropped nucleus)
- •Prior intraocular surgery in the study eye (vitrectomy, glaucoma surgery, or previous cataract surgery)
- •Prior intravitreal injection before cataract surgery
- •Prior posterior-segment or macular laser photocoagulation within 6 months before surgery
- •Uveitis, retinal vein occlusion, retinal detachment, or any non-diabetic retinal pathology
- •Prostaglandin-analogue use at the time of surgery
- •Type 1 diabetes mellitus (may be examined in a sensitivity analysis)
- •Insufficient data (missing HbA1c, renal function, or postoperative OCT)
- •Bilateral simultaneous surgery (only the first operated eye is included if surgery is sequential)
研究组 & 干预措施
No baseline nephropathy (unexposed)
Patients with type 2 diabetes without baseline diabetic nephropathy (UACR <30 mg/g and eGFR ≥60 mL/min/1.73 m²) and with well-controlled glycemia (HbA1c ≤7%) at the time of phacoemulsification.
干预措施: Phacoemulsification with posterior-chamber IOL (Other)
Baseline nephropathy and/or elevated HbA1c (exposed)
Patients with type 2 diabetes who have baseline diabetic nephropathy (UACR ≥30 mg/g and/or eGFR <60 mL/min/1.73 m²) and/or elevated preoperative HbA1c (>7%) at the time of phacoemulsification.
干预措施: Phacoemulsification with posterior-chamber IOL (Other)
结局指标
主要结局
Incidence of pseudophakic macular edema (PME)
时间窗: 1 month and 3 months after surgery
Proportion of operated eyes with a ≥30% increase in optical coherence tomography (OCT)-measured central macular thickness (central 1-mm subfield, ETDRS grid) from preoperative baseline, on spectral-domain OCT, graded by two masked ophthalmologists.
次要结局
- Absolute change in central macular thickness (CMT)(1 month and 3 months.)
- Best-corrected visual acuity (BCVA)(1 month and 3 months.)
- Time to PME onset(up to 3 months.)
- PME resolution rate(3 months.)
- ROC-derived optimal preoperative HbA1c cut-point(at analysis (baseline predictor vs 3-month outcome).)
- Time to Pseudophakic Macular Edema (PME) onset(up to 3 months.)
研究者
Wit Tharanon
Research fellow in Ophthalmology, Faculty of medicine, Thammasat University
Thammasat University Hospital