Active — Not RecruitingNot Applicable

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

Thailand428 participantsStarted 2026-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 postoper…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of pseudophakic macular edema (PME)

Timeframe: 1 month and 3 months after surgery

Trial details

NCT IDNCT07723846

SponsorThammasart University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-11-01

View on ClinicalTrials.gov More Pseudophakic Macular Edema trials