Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07407049

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Age-related cataract
  • Nuclear opacity (N) graded ≥4 according to the Lens Opacities Classification System III (LOCS III)
  • Scheduled for phacoemulsification with intraocular lens implantation
  • Pupil size ≥6 mm after dilation
  • Corneal endothelial cell density ≥1500 cells/mm²

Exclusion criteria

  • 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.
  • Currently participating in another clinical trial
  • History of ocular trauma or surgery
  • Presence of other ocular diseases (e.g., glaucoma, diabetic retinopathy)
  • Other ocular factors that may complicate surgery (e.g., small pupil, shallow anterior chamber)

Treatment and study plan

Supracapsular Phacoemulsification

Procedure

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

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.

Primary outcomes

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

    Time frame: 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.

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

  5. Corneal endothelial cell density

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

  6. The best-corrected distance visual acuity at other time frame

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

Study contacts

Contact information is provided by the study sponsor or research team.

Zitian Liu

CONTACT

[email protected]

020-66610729

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.