NCT07723846Active, not recruiting
Diabetic Nephropathy, Glycemic Control and Pseudophakic Macular Edema After Cataract Surgery
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.
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 428 (estimated)
- First submitted
- 19 Jul 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Thammasat University Hospital
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT07723846
What you commit to
- Study type: Observational
- Planned participants: 428
- From 1 Jun 2026 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Prostaglandin-analogue use at the time of surgery
- Bilateral simultaneous surgery (only the first operated eye is included if surgery is sequential)
Other illness
- Type 1 diabetes mellitus (may be examined in a sensitivity analysis)
Lab values
- Insufficient data (missing HbA1c, renal function, or postoperative OCT)
Age
- 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)
Other
- Intraoperative complication (posterior-capsule rupture, vitreous loss, zonulolysis, or dropped nucleus)
- Uveitis, retinal vein occlusion, retinal detachment, or any non-diabetic retinal pathology
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thammasat University Hospital, Department of Ophthalmology Coordinator of this site? Confirm its status | Pathum Thani | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.