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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-90
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Patients who are planning to receive phacoemulsification combined with intraocular lens implantation for unilateral/bilateral age-related cataract

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • cataract surgery

    Procedure/Surgery

    Cataract phacoemulsification combined with intraocular lens implantation

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Phacoemulsification1 intervention

Trial outcomes

Primary outcomes

1

Change in corneal thickness

Corneal thickness measured by corneal endothelial specular microscope

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

Secondary outcomes

1

Change in corneal endothelial cell density

Measured using corneal endothelial specular microscope

Time frame
1 day, 1 week, and 1 month postoperatively
2

Best-corrected visual acuity

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

Time frame
1 day, 1 week, and 1 month postoperatively
3

Intraoperative and postoperative complications

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

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

Other outcomes

1

Position of 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.

Time frame
During phacoemulsification

Sponsors and contacts

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