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NCT Number: NCT07550907

The Impact of Surgical Procedures on Postoperative Outcomes in Cataract Phacoemulsification and Analysis of Related Factors

The goal of this observational study is to evaluate the location of phacoemulsification tip measured by intraoperative OCT during cataract surgeries and its impact on early postoperative changes of cornea and visual acuity. The main question it aims to answer is:

In patients with age-related cataracts undergoing phacoemulsification, does the location (supracapsular, iris-lens diaphragm, or endocapsular) of the phaco tip affect postoperative corneal changes and visual acuity at early postoperative stage? Eyes having phacoemulsification for cataracts will receive intraoperative OCT imaging to evaluate the location of the phaco tip during surgery, and corneal changes and visual acuity will be measured postoperatively.

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Key information

Conditions

Age-related Cataract

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Zitian Liu, MD, PhD

CONTACT

[email protected]

+8618319249014

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
  • Diagnosis of unilateral/bilateral age-related cataract
  • Nuclear grade ≥2 in LOCSIII classification
  • Scheduled for cataract phacoemulsification combined with intraocular lens implantation
  • Pupil size ≥6mm after dilation
  • Corneal endothelial cell count ≥1500 cells/mm²

Exclusion criteria

  • Diagnosis of severe systemic disease (e.g., severe hypertension or Alzheimer's disease)
  • History of ocular trauma or surgery
  • Presence of other ocular diseases (such as glaucoma, diabetic retinopathy, or high myopia)
  • Other ocular factors that may complicate the surgery (such as small pupil, shallow anterior chamber)

Treatment and study plan

cataract surgery

Procedure

Cataract phacoemulsification combined with intraocular lens implantation

Primary outcomes

  1. Change in corneal thickness

    Time frame: postoperative day 1, week 1, and month 1

    Corneal thickness measured by corneal endothelial specular microscope

Secondary outcomes

  1. Change in corneal endothelial cell density

    Time frame: 1 day, 1 week, and 1 month postoperatively

    Measured using corneal endothelial specular microscope

  2. Best-corrected visual acuity

    Time frame: 1 day, 1 week, and 1 month postoperatively

    Measured using ETDRS visual acuity protocol with ETDRS visual acuity chart by a masked examiner

  3. Intraoperative and postoperative complications

    Time frame: Intraoperative, 1 day, 1 week, and 1 month postoperatively

    Monitored by cataract surgeons using intraoperative OCT and postoperative slit-lamp examination. Complications include Descemet membrane detachment, posterior capsule rupture, incision leakage, and etc.

Other outcomes

  1. Position of Phacoemulsification

    Time frame: During phacoemulsification

    Swept-source intraoperative optical coherence tomography (SS-iOCT) will be used for real-time measurements throughout the surgery. The imaging depth will be set to 12 mm to ensure full visualization from the anterior corneal surface to the posterior lens surface. During phacoemulsification, a five-line scanning pattern will be applied, with the central line aligned with the phaco tip. The iris-lens diaphragm plane will be used as the reference standard on iOCT images. The phaco tip will be considered to be in the supracapsular space when positioned above this plane, at the iris-lens diaphragm plane when exactly at the plane, and in the endocapsular space when positioned below the plane. The duration of phaco tip manipulation in the supracapsular space, at the iris-lens diaphragm plane, and in the endocapsular space will be recorded throughout the phacoemulsification process.

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
2027
First posted
Apr 24, 2026
Registry last updated
Jun 3, 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.

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