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

Active, not recruiting

• Conditions: Cataract

• Registration Number: NCT06707740
• Lead Sponsor: Wenzhou Medical University

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.

Detailed Description

To compare the difference of rotational stability and CBI between AcrySof IQ(SN6AT) and TECNIS (ZCU) torus intraocular lenses implanted after cataract surgery, and analyze the influence of capsular bag bending on the rotational stability of two kinds of astigmatism correction intraocular lenses after cataract surgery.

Study Timeline

• Study Start: 2024-10-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-24
• Last Update Submitted: 2024-11-24
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1.The patient's age is over 18 years old. 2.Diagnosed as age-related cataract Corneal astigmatism measured before operation is > 0.75 D or predicted after operation after taking into account surgical astigmatism (SIA).

3.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).

5.After operation, the anterior capsule completely covered the edge of intraocular lens optical surface.

6.Able to understand, cooperate and complete all follow-up.

Exclusion Criteria

1. Moderate and severe dry eye

2. There is irregular corneal astigmatism.

3. Combined with other ophthalmic diseases Previous history of ophthalmic surgery.

4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Capsular bend index	1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.	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.
IOL rotation degree	1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.	The difference of degrees between the actually measured Toric IOL astigmatism axes at two adjacent follow-up time points.
Toric IOL total axial deviation	1-2 hours after operation, 1 day, 1 week, 1 month and 3 months.	The degree difference between the actual axial position and the target axial position of Toric IOL is different.

Trial Locations

Locations (1)

Ophthalmology and Optometry Hospital; 🇨🇳 Wenzhou, Wenzhou, China