This study was conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of Beijing Tsinghua Changgung Hospital (Approval No. 26875-6-01), which provided ethics oversight for the retrospective cohort enrolled at Beijing Tongren Hospital, Mentougou Campus. The requirement for research-informed consent was waived because of the retrospective study design. The study workflow is shown in Figure 1. The instruments, consumables, medications, and software used in the protocol are listed in the Table of Materials.

Figure 1: Study workflow. Workflow of participant enrollment, eligibility assessment, group allocation, surgical procedures, postoperative assessments, and follow-up for patients undergoing small-incision cataract surgery (SICS) or phacoemulsification (PE). Follow-up examinations were performed at 1 week, 1 month, 3 months, and 6 months postoperatively. Please click here to view a larger version of this figure.
1. Study participants
This retrospective case-control study enrolled 165 patients (165 eyes) with age-related cataracts who underwent surgery in the Department of Ophthalmology, Beijing Tongren Hospital, Mentougou Campus, Beijing, China, between January 2021 and February 2023. All cataract surgeries and perioperative clinical assessments were performed at Beijing Tongren Hospital, Mentougou Campus, and the study data were reviewed under the ethics oversight of Beijing Tsinghua Changgung Hospital. Eighty-three patients underwent small-incision cataract surgery (SICS group), and 82 underwent phacoemulsification (PE group). The sample size was calculated using G*Power with α = 0.05 and a power of 0.95, yielding a minimum requirement of 134 cases. Therefore, the final sample size of 165 cases was considered adequate.
Eligible participants had age-related cataracts diagnosed according to the Clinical Guidelines of Ophthalmology (China)10 and type 2 diabetes mellitus diagnosed according to the China Guideline for Type 2 Diabetes (2020 Edition)11. Additional eligibility requirements included lens nuclear hardness grade III or IV according to the Emery–Little classification, supplemented by quantitative lens density grading; fasting venous blood glucose < 8.0 mmol/L on two consecutive measurements before surgery; corneal endothelial cell density (CECD) ≥ 2,000 cells/mm2 with a hexagonal cell ratio > 50%; complete preoperative, intraoperative, and 6-month postoperative follow-up data; and uncomplicated surgery without posterior capsular rupture. Routine written consent for cataract surgery was obtained as part of standard clinical care, whereas study-specific research consent was waived because of the retrospective study design.
Patients were excluded if they had corneal astigmatism, keratoconjunctival disease, keratoconus, iritis, glaucoma, significant vitreous opacity, macular edema, high myopia with fundus lesions, other systemic or ocular contraindications, a history of ocular trauma or intraocular surgery, diabetic retinopathy or other retinal pathology affecting vision, abnormal renal function, diabetic peripheral neuropathy, or moderate-to-severe preoperative dry eye disease or ocular surface disease.
2. Surgical procedures
Preoperative evaluations included intraocular lens (IOL) power calculation using the SRK/T formula, slit-lamp biomicroscopy, noncontact specular microscopy, and anterior segment optical coherence tomography (AS-OCT). All surgeries were performed by the same senior surgeon under topical anesthesia.
In the SICS group, a 5.5 mm scleral tunnel incision, continuous curvilinear capsulorhexis, hydrodissection, nucleus delivery, cortical aspiration, and IOL implantation were performed. The incision was closed in a watertight manner. Operative duration and nuclear delivery difficulty grading were recorded.
In the PE group, a 3.0 mm clear corneal incision, continuous curvilinear capsulorhexis, phacoemulsification of the lens nucleus, cortical aspiration, and IOL implantation were performed. The incision was hydrated for closure. Operative duration, cumulative dissipated energy (CDE), intraoperative ultrasound power, quantitative phacoemulsification parameters, and balanced salt solution (BSS) irrigation volume were recorded.
Postoperative medications were standardized for all patients and consisted of levofloxacin eye drops four times daily for 2 weeks, prednisolone acetate eye drops four times daily, tapered over 4 weeks, pranoprofen eye drops four times daily for 4 weeks, and recombinant bovine basic fibroblast growth factor ophthalmic gel twice daily for 4 weeks. The postoperative medication regimen was identical in both groups. Intraocular pressure > 21 mmHg was managed with antiglaucoma medications.
3. Outcome measures
Patients were evaluated preoperatively and at 1 week and 1, 3, and 6 months postoperatively. At each visit, best-corrected visual acuity (BCVA), tear film break-up time (TBUT), Schirmer I test (SIT), corneal endothelial cell density (CECD), and central corneal thickness (CCT) were assessed. BCVA values were converted to logarithm of the minimum angle of resolution (LogMAR) units for statistical analysis.
TBUT was measured using fluorescein staining. A sterile fluorescein strip was moistened with one drop of topical antibiotic solution and applied to the inferior conjunctival sac. After gentle blinking, TBUT was measured under cobalt blue illumination. Three consecutive measurements were obtained and averaged for analysis. The same procedure was used for all participants at all study visits.
SIT was performed without topical anesthesia. A standardized Schirmer strip was placed in the lateral third of the lower conjunctival sac, and patients were instructed to gently close their eyes for 5 min without squeezing. The wetted length was recorded in millimeters. All SIT measurements were performed by the same experienced technician.
CECD was measured using noncontact specular microscopy, and three central images were averaged. CCT was measured using AS-OCT. To minimize physiological variability, CECD and CCT measurements were performed between 9:00 and 11:00 AM in a temperature-controlled examination room. Examiners were masked to group allocation and followed identical acquisition procedures throughout the study.
4. Statistical analysis
Data were analyzed using SPSS. Categorical variables were analyzed using the chi-square test. Continuous variables are presented as mean ± standard deviation (
± s) and were analyzed using the independent-samples t-test. Repeated-measures analysis of variance (RM-ANOVA) was performed for each primary endpoint (BCVA, TBUT, SIT, CECD, and CCT) to quantify three statistical effects separately: Firstly, the main time effect (within-subject change across follow-up visits), secondly, the main group effect (overall difference between SICS and PE regardless of time), and lastly, the group × time interaction effect (differences in postoperative change trajectories between the two surgical groups). Sphericity testing was performed, and the Greenhouse–Geisser correction was applied when the sphericity assumption was violated. A Bonferroni post hoc correction was used for pairwise within-group comparisons with the preoperative baseline and for comparisons between consecutive follow-up time points. Exact F-statistics and P-values are reported for the time, group, and interaction effects of each RM-ANOVA. Group × time interactions were assessed. A P value < 0.05 was considered statistically significant.