Comparison of the Effect of Capsular Bend on the Rotational Stability Between Two Toric Intraocular Lenses

NCT06707740 | Active Not Recruiting

• 1 other identifier: SSOCT-toric
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

(1) To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS(ZCU) after cataract surgery. (2) To evaluate the influence of capsular bending on the rotational stability of these two kinds of intraocular lenses.

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

• Capsular bend index

  The average value of the capsular bag bending stage in different positions of IOL represents the speed of the whole capsular bag bending formation in the eye.

  1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.

• IOL rotation degree

  The difference of degrees between the actually measured Toric IOL astigmatism axes at two adjacent follow-up time points.

  1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.

• Toric IOL total axial deviation

  The degree difference between the actual axial position and the target axial position of Toric IOL is different.

  1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.

Study Arms (2)

Group 1 AcrySof IQ(SN6AT) implantation after cataract surgery.

Group 2TECNIS（ZCU） implantation after cataract surgery.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation"

You may qualify if:

• Pupil diameter \> 7 mm after mydriasis. 4.The astigmatism meridian between IOLMaster and Pentacam is the same (the meridian difference between the two instruments is within 15).
• After operation, the anterior capsule completely covered the edge of intraocular lens optical surface.
• Able to understand, cooperate and complete all follow-up.

You may not qualify if:

• Moderate and severe dry eye
• There is irregular corneal astigmatism.
• Combined with other ophthalmic diseases Previous history of ophthalmic surgery.
• The capsulorhexis is too large or eccentric, which can not cover the optical zone of intraocular lens all around, and there are intraoperative or postoperative complications.

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Ophthalmology and Optometry Hospital

Wenzhou, Wenzhou, Zhejiang 325027, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: October 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)