Rotational Stability of Different Intraocular Lenses in The Capsular Bag

NCT03761745 | Completed

• 1 other identifier: 2018Rotation
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the rotational stability difference among different intraocular lens. The rotational stability is evaluated by measurement of rotation of the IOL after surgery.

Conditions

Intraocular Lens Complication; Phacoemulsification

Keywords

Rotation; Postoperative Care

Outcome Measures

Primary Outcomes (3)

• Alignment of intraocular lens

  The alignment of intraocular lens was evaluated by anterior segment photography

  1 day postoperatively

• Alignment of intraocular lens

  The alignment of intraocular lens was evaluated by anterior segment photography

  1 week postoperatively

• Alignment of intraocular lens

  The alignment of intraocular lens was evaluated by anterior segment photography

  1 month, postoperatively

Secondary Outcomes (3)

• Intraocular Pressure

  1 day, 1 week, 1 month, postoperatively

• Corrected Visual Acuity (UCVA) at Distance

  1 day, 1 week, 1 month, postoperatively

• Uncorrected Visual Acuity (UCVA) at Distance

  1 day, 1 week, 1 month, postoperatively

Eligibility Criteria

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

Study Population

Patients who received Femtosecond laser-assisted phacoemulsification surgery in The Eye Hospital of Wenzhou Medical University

You may qualify if:

• Age ≥ 18 years
• Patients who had received Femtosecond laser-assisted phacoemulsification surgery with IntelliAxis-L capsular mark.
• The operation was smooth and there were no surgical complications.

You may not qualify if:

• Corneal and other ocular diseases (such as corneal opacity, keratitis, glaucoma, uveitis, lens dislocation or subluxation, lens capsule relaxation, retinopathy, etc.);
• History of ocular trauma or surgery before this cataract surgery;
• intraoperative and postoperative complications, such as posterior capsule rupture, corneal endothelium decompensation;
• Patients with severe or unstable heart, liver, kidney, lung, endocrine (including thyroid dysfunction), blood, mental dysfunction and other diseases affect the results of this study;

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Eye Hispital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Study Officials

• AYong Yu, MD.PhD.

  Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rotational Stability of Different Intraocular Lenses in The Capsular Bag

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: December 3, 2018
• Study Start: December 29, 2018
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)