Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571773
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Evaluation of Toric Intraocular LensIOL Combined with Capsular Tension RingCTR in Patients with Cataract Combined with High Myopia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Astigmatism-correcting IOL Combined with Tension Ring on Postoperative Visual Quality and Rotational Stability of IOLs in Patients with Cataract Combined with High Myopia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the postoperative visual quality and IOL stability in patients with cataracts and high myopia who have undergone surgery using astigmatism-correcting IOLs in conjunction with tension ringsIt is a non-randomised retroprospective cohort study Patients with high axial myopia AL 26 mm who underwent cataract phacoemulsification combined with toric IOLAcrysof SN6ATY IQ toric IOL Alcon Alcon Laboratories Fort Worth Texas USA implantation from October 2020 to September 2023 at the Shanghai Tenth Peoples Hospital are selected According to the usage of CTR all patients will be divided into CTR group and control group with a minimum follow-up of 3 monthsEach patient underwent a comprehensive preoperative examination and ophthalmological examinations at the outpatient clinic 1 day 1 week 1 month and 3 months postoperativelyStatistical analysis will be conducted using SPSS 260 statistical software
Detailed Description:
Preoperative examinationEach patient underwent a comprehensive preoperative examination which included evaluation of uncorrected visual acuity UCVA best corrected visual acuity BCVA corneal endothelial cells CECs axial length corneal curvature and corneal topography using subjective optometry slit-lamp microscopy funduscopic examination intraocular pressure measurements B-scan ultrasound of the eye and corneal topographyPentacam HR OCULUS Optikgerate Wetzlar Germany as well as other relevant parameters Visual acuity was measured using a standard logarithmic visual acuity chart Biometry of the operative eye was performed by a specialized technician using an IOL Master IOLMaster 700 Carl Zeiss Meditec Jena Germany and the Barrets formulaⅡ was applied to calculate the equivalent spherical equivalent SE of the toric IOL The information was inputted into an online calculator wwwacrysoftoriccalculatorcom provided by Alcon to determine the necessary IOL refraction and axial position
SurgeryThe patients received tobramycin dexamethasone eye drops four times one day before surgery Prior to surgery the IOL axial position the diameter size of continuous curvilinear capsulorhexis CCC and the incision position were measured and marked using the Image Guided SystemVERION Reference Unit Alcon GPS-WaveLight GmbH Rheinstrasse Germany The pupil was dilated with compound tropicamide drops to a diameter of at least 8mm The surgery was performed by an experienced surgeon following a standardized procedure The surgical procedure was as follows Proparacaine hydrochloride eye drops ALCAINE SAAlcon-Couvreur NV Belgium were used to provide surface anaesthesia The conjunctival sac was rinsed with 1 povidone-iodine Afterwards a 22-mm corneal incision and a 15 stab knife auxiliary incision were made under the guidance of digital navigation system Inserting the viscoelastic into the anterior chamber and applying a continuous circular capsulorhexis method a complete hydro dissection was performed The lens nucleus was removed using ultrasonic emulsification follow by aspirating the excess cortex and polishing the capsule After propping up the capsular bag with viscoelastic the intraocular lens IOL was implanted through the main incision the CTR would be implanted before the IOL implantation After suctioning off the viscoelastic the IOL was adjusted to the predetermined axis under navigation guidance Finally the incision was hydrated Tobramycin dexamethasone eye drops were used for 2 weeks postoperatively in all cases
Postoperative managementAll patients underwent ophthalmological examinations at the outpatient clinic 1 day 1 week 1 month and 3 months postoperatively The examinations included uncorrected distance visual acuity intraocular pressure examination subjective optometry slit lamp microscopy and SS-OCT CASIA2 Tomey Corporation Nagoya Japan The surgeon using the same slit lamp microscope and a narrow band of light measured the IOL axial position after the patients pupils were fully dilated with compound tropicamide eye drops The rotation degree was calculated as the absolute difference between the axial positions of the check and target
SurgeryThe patients received tobramycin dexamethasone eye drops four times one day before surgery Prior to surgery the IOL axial position the diameter size of continuous curvilinear capsulorhexis CCC and the incision position were measured and marked using the Image Guided SystemVERION Reference Unit Alcon GPS-WaveLight GmbH Rheinstrasse Germany The pupil was dilated with compound tropicamide drops to a diameter of at least 8mm The surgery was performed by an experienced surgeon following a standardized procedure The surgical procedure was as follows Proparacaine hydrochloride eye drops ALCAINE SAAlcon-Couvreur NV Belgium were used to provide surface anaesthesia The conjunctival sac was rinsed with 1 povidone-iodine Afterwards a 22-mm corneal incision and a 15 stab knife auxiliary incision were made under the guidance of digital navigation system Inserting the viscoelastic into the anterior chamber and applying a continuous circular capsulorhexis method a complete hydro dissection was performed The lens nucleus was removed using ultrasonic emulsification follow by aspirating the excess cortex and polishing the capsule After propping up the capsular bag with viscoelastic the intraocular lens IOL was implanted through the main incision the CTR would be implanted before the IOL implantation After suctioning off the viscoelastic the IOL was adjusted to the predetermined axis under navigation guidance Finally the incision was hydrated Tobramycin dexamethasone eye drops were used for 2 weeks postoperatively in all cases
Postoperative managementAll patients underwent ophthalmological examinations at the outpatient clinic 1 day 1 week 1 month and 3 months postoperatively The examinations included uncorrected distance visual acuity intraocular pressure examination subjective optometry slit lamp microscopy and SS-OCT CASIA2 Tomey Corporation Nagoya Japan The surgeon using the same slit lamp microscope and a narrow band of light measured the IOL axial position after the patients pupils were fully dilated with compound tropicamide eye drops The rotation degree was calculated as the absolute difference between the axial positions of the check and target
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None