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

NCT07550907 | Not Yet Recruiting

• 1 other identifier: IIT2025172
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Age-related Cataract

Outcome Measures

Primary Outcomes (1)

• Change in corneal thickness

  Corneal thickness measured by corneal endothelial specular microscope

  postoperative day 1, week 1, and month 1

Secondary Outcomes (3)

• Change in corneal endothelial cell density

  1 day, 1 week, and 1 month postoperatively

• Best-corrected visual acuity

  1 day, 1 week, and 1 month postoperatively

• Intraoperative and postoperative complications

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

Other Outcomes (1)

• Position of Phacoemulsification

  During phacoemulsification

Study Arms (1)

Phacoemulsification

Procedure: cataract surgery

Interventions

cataract surgery PROCEDURE

Cataract phacoemulsification combined with intraocular lens implantation

Phacoemulsification

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Related Publications (6)

• Liu Z, Lin H, Jin L, Qu B, Liu J, Zheng Y, He M, Luo L, Liu Y. Swab Pressing vs Stromal Hydration to Prevent Incision Leakage and Transient Collapse of Anterior Chamber in Phacoemulsification: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Jun 1;141(6):574-581. doi: 10.1001/jamaophthalmol.2023.1491.

  PMID: 37166786 BACKGROUND

• Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044.

  PMID: 17276271 BACKGROUND

• Dewan T, Malik PK, Kumari R. Comparison of effective phacoemulsification time and corneal endothelial cell loss using 2 ultrasound frequencies. J Cataract Refract Surg. 2019 Sep;45(9):1285-1293. doi: 10.1016/j.jcrs.2019.04.015. Epub 2019 Jul 29.

  PMID: 31371150 BACKGROUND

• Dewan T, Malik PK, Tomar P. Comparison of effective phacoemulsification time and corneal endothelial cell loss using three different ultrasound frequencies: A randomized controlled trial. Indian J Ophthalmol. 2022 Apr;70(4):1180-1185. doi: 10.4103/ijo.IJO_2163_21.

  PMID: 35326010 BACKGROUND

• Liu Y, Jiang Y, Wu M, Liu Y, Zhang T. Bimanual microincision phacoemulsification in treating hard cataracts using different power modes. Clin Exp Ophthalmol. 2008 Jul;36(5):426-30.

  PMID: 18939349 BACKGROUND

• Lundberg B, Jonsson M, Behndig A. Postoperative corneal swelling correlates strongly to corneal endothelial cell loss after phacoemulsification cataract surgery. Am J Ophthalmol. 2005 Jun;139(6):1035-41. doi: 10.1016/j.ajo.2004.12.080.

  PMID: 15953433 BACKGROUND

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 24, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share