Comparison of Early Postoperative Visual Acuity Between Intracapsular and Supracapsular Phacoemulsification: A Randomized Controlled Clinical Trial

ConditionCataract
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

Cataracts are the leading cause of blindness worldwide, and phacoemulsification combined with intraocular lens implantation has become the most mainstream surgical approach. With advancements in surgical techniques and equipment, this procedure has evolved from a simple vision-restoring surgery into the era of refractive surgery. Patients now have higher expectations for postoperative visual quality, particularly the recovery of early vision, which directly impacts their satisfaction. Intraoperative surgical details have a direct influence on postoperative visual acuity.

Thanks to intraoperative optical coherence tomography (iOCT) technology, surgeons have gradually recognized that factors such as surgical incisions and intraoperative anterior chamber collapse can affect the survival of corneal endothelial cells after surgery, which is directly related to early postoperative vision and patient satisfaction. Swept-source intraoperative OCT (SS-iOCT) has further improved imaging range and clarity, helping us discover that the depth of intraoperative ultrasound energy use (such as cumulative dissipated energy) correlates with postoperative corneal endothelial cell loss. This suggests that compared to performing phacoemulsification at the capsular opening plane or in the anterior chamber, intracapsular phacoemulsification may reduce postoperative corneal endothelial cell loss, potentially leading to better early postoperative vision, which is crucial for patient satisfaction. However, evidence is still lacking.

Therefore, this study aims to compare the effects of intracapsular versus extracapsular phacoemulsification on early postoperative vision, as well as long-term visual acuity, corneal endothelial cells, corneal changes, and the incidence of intraoperative and postoperative complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 50 years and ≤ 90 years

Able to cooperate with preoperative examinations

At least one eye meets the study eye criteria

Has the capacity and willingness to provide informed consent

Disqualifiers

Considered unsuitable by the investigator for participation in this clinical trial for other reasons (e.g., unstable systemic condition, uncontrolled blood pressure/blood glucose, severe cardiovascular disease, renal disease, etc.)

Blood pressure > 180/110 mmHg (systolic >180 mmHg or diastolic >110 mmHg). Patients may be considered for inclusion if blood pressure can be controlled below these thresholds with medication.

History of myocardial infarction or other cardiac disease requiring hospitalization, cerebral infarction, transient ischemic attack, or acute heart failure within 4 months prior to enrollment.

Women with childbearing potential (i.e., currently pregnant, breastfeeding, or planning to become pregnant within the next 2 years). Women of childbearing potential should be asked about the possibility of pregnancy, and the investigator will determine when a pregnancy test is necessary.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Supracapsular Phacoemulsification

    Procedure/Surgery

    During phacoemulsification, real-time imaging of the anterior segment was performed using SS-iOCT (Tupai, China), but the surgeon was not able to view the images. The surgeon was instructed to proceed with phacoemulsification as per routine, using phaco energy (i.e., level 3). All other surgical steps were identical to conventional surgery.

  • Intracapsular Phacoemulsification

    Procedure/Surgery

    During phacoemulsification, real-time imaging of the anterior segment was performed using SS-iOCT (Tupai, China). The surgeon was required to confirm under SS-iOCT guidance that the phaco tip was located within the capsular bag (as judged by two observers not involved in the surgery) before applying phaco energy (i.e., level 3). All other surgical steps were identical to conventional surgery.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Supracapsular PhacoemulsificationActive comparator 1 intervention
Group B: Intracapsular PhacoemulsificationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The best-corrected distance visual acuity at 1 day postoperatively.

It was evaluated using the ETDRS visual acuity chart by a masked optometrist, with the examination procedure following the standard ETDRS visual acuity testing protocol, and the unit of measurement was logMAR.

Time frame
1 day postoperatively

Secondary outcomes

1

Coefficient of variation of corneal endothelial cell size

Time frame
Post-operative day 1, week 1, month 1, month 3, month 6
2

The percentage loss of central corneal endothelial cell density compared to the preoperative baseline at post-operative day 1 and post-operative

Time frame
1 day and 1 month postoperatively
3

Percentage of hexagonal cells

Time frame
Post-operative day 1, week 1, month 1, month 3, month 6
4

Central corneal thickness

Time frame
Post-operative day 1, week 1, month 1, month 3, month 6

Other outcomes

Sponsors and contacts

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