Diabetic Nephropathy, Glycemic Control and Pseudophakic Macular Edema After Cataract Surgery

NCT07723846 | Active Not Recruiting

• 1 other identifier: MTU-EC-OP-0-188/69
• Study Type: observational
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pseudophakic Macular Edema; Diabetic Nephropathies; Diabetes Mellitus, Type 2; Cataract (Post-operative Cataract Surgery Follow-up); Cataract and IOL Surgery

Keywords

pseudophakic macular edema; diabetic nephropathy; phacoemulsification; HbA1c; central macular thickness; optical coherence tomography; UACR; eGFR; KDIGO; cataract surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of pseudophakic macular edema (PME)

  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.

  1 month and 3 months after surgery

Secondary Outcomes (5)

• Absolute change in central macular thickness (CMT)

  1 month and 3 months.

• Best-corrected visual acuity (BCVA)

  1 month and 3 months.

• Time to Pseudophakic Macular Edema (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).

Study Arms (2)

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.

Other: Phacoemulsification with posterior-chamber IOL

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.

Other: Phacoemulsification with posterior-chamber IOL

Interventions

Phacoemulsification with posterior-chamber IOL OTHER

Uncomplicated phacoemulsification cataract surgery with posterior-chamber intraocular lens implantation. The observed exposure of interest is baseline diabetic nephropathy and preoperative glycemic status (used to define the two cohorts).

Baseline nephropathy and/or elevated HbA1c (exposed); No baseline nephropathy (unexposed)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with type 2 diabetes mellitus who underwent uncomplicated phacoemulsification with posterior-chamber intraocular lens implantation in the in-patient and out-patient services of the Department of Ophthalmology, Thammasat University Hospital, during the study window, and who have a preoperative HbA1c, a preoperative renal function assessment (eGFR and/or UACR), and baseline and postoperative macular OCT documented in the electronic medical record.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thammasart University Hospital: lead
• Thammasat University: collaborator
• Thammasat University Hospital: collaborator

Study Sites (1)

Thammasat University Hospital, Department of Ophthalmology

Pathum Thani, Khlong Luang, 12120, Thailand

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 2; Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Nattapon Wongcumchang, Associate Professor

  Vitreoretinal unit, Department of Ophthalmology, Faculty of medicine, Thammasat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research fellow in Ophthalmology, Faculty of medicine, Thammasat University

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)