Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05161520
Other study ID # 2021KYPJ128
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 16, 2021
Est. completion date December 2024

Study information

Verified date April 2023
Source Zhongshan Ophthalmic Center, Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized controlled trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) tilt and decentration in cataract patients with high myopia.


Description:

Exact positioning and alignment of the IOL with the visual axis are the prerequisites of high-quality visual performance after cataract surgery. A certain degree of IOL tilt and decentration occur after uneventful cataract surgery, most of which are clinically tolerant. However, the relatively large capsular bag volume, zonular weakness, and vitreous liquefaction in cataract patients with high myopia may increase the IOL position instability, such as tilt, decentration and even dislocation, leading to the deterioration of visual function. Thus, how to improve the long-term stability of IOL position in high myopic cataract patients is an urgent issue to be addressed. Previous studies have shown that CTR implantation during cataract surgery can increase the IOL stability in patients with normal axial length; however, its impact on IOL position of cataract patients with high myopia remains unclear. In this randomized clinical trial, patients who meet the inclusion criteria will be divided into three layers according to the axial length: (1)26mm≤AL<28mm (2)28mm≤AL<30mm (3)AL≥30mm We are going to recruit 186 patients in total, with 62 patients in each layer. Patients on each layer will be randomly divided into experimental group (CTR implantation) and control group (only IOL implantation). If both eyes of a patient meet the inclusion criteria, only the first operated eye is included in the statistics analysis. All included patients will be followed up at 1 week, 1 month, 3 months, 6 months, and 1 year postoperatively. Visual acuity, IOL tilt, IOL decentration, posterior capsule attachment with IOL, anterior capsule contraction, posterior capsular opacification, and visual quality will be measured and compared between the experimental group and the control group at different timepoints.


Recruitment information / eligibility

Status Recruiting
Enrollment 186
Est. completion date December 2024
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. > 18 years old; 2. axis length=26mm; 3. Visually significant cataract; 4. The patient is willing and able to complete all necessary follow-ups and examinations. Exclusion Criteria: 1. Intraoperative or postoperative complications: such as intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, endophthalmitis, etc.; 2. Other ocular comorbidity: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.; 3. History of intraocular surgery; 4. Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.; 5. Any condition that the study physician considers to be an impediment to the clinical trial.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
phacoemulsification combined with IOL and CTR implantation
Device: CTR (276001G; OPHTEC BV, Netherlands) Device: IOL (920H; Rayner Intracular Lenses Limited,Hove,East Sussex,UK) All patients undergo uneventful phacoemulsification by a 3.0 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, a capsular tension ring is implanted in the capsular bag and then IOL is implanted.
phacoemulsification combined with IOL implantation
Device: IOL (920H; Rayner Intracular Lenses Limited,Hove,East Sussex,UK) All patients undergo uneventful phacoemulsification by a 3.0 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag.

Locations

Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Xuhua Tan

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary IOL dencentration Measured by anterior segment OCT (CASIA2) 3 months after surgery
Secondary IOL dencentration Measured by anterior segment OCT (CASIA2) Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery
Secondary IOL tilt Measured by anterior segment OCT (CASIA2) Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery
Secondary Anterior capsule contraction Compare the area of anterior capsule opening recorded by slit lamp photograph and analyzed by Image J software. Baseline, 1 week, 1 month, 3 months, 6 months, 1 year after surgery
Secondary Posterior capsule attachment with IOL Measured by anterior segment OCT (CASIA2) and analyzed by Image J software. 1 week, 1 month, 3 months, 6 months, 1 year after surgery
Secondary Posterior capsular opacification Recorded by slit lamp photograph and analyzed by EPCO2000 analysis software. 1 week, 1 month, 3 months, 6 months, 1 year after surgery
Secondary BCVA BCVA is evaluated with ETDRS visual acuity chart. Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery
Secondary Optical quality Measured by OPD-SCAN III. Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery
Secondary Visual function Measured by visual function assessment questionnaires. 3 months, 6 months, 1 year after surgery
See also
  Status Clinical Trial Phase
Completed NCT04685538 - Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification. Phase 3
Recruiting NCT06060041 - IC-8 Apthera IOL New Enrollment Post Approval Study
Recruiting NCT05518539 - Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
Recruiting NCT05271942 - Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods N/A
Active, not recruiting NCT04778501 - PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia N/A
Completed NCT05062564 - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye N/A
Completed NCT03751033 - Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings N/A
Completed NCT02529488 - Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00 N/A
Completed NCT04539548 - A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract Phase 3
Completed NCT03740659 - Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery Phase 2
Completed NCT03494257 - Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification N/A
Completed NCT05119127 - Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome. N/A
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT03739528 - Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery Phase 3
Completed NCT02888210 - A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery Phase 3
Completed NCT03356847 - Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery N/A
Completed NCT04332640 - Clinical Evaluation of the Next Generation Phaco System N/A
Recruiting NCT03638726 - Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification Phase 4
Completed NCT03050697 - Evaluation of the Safety and Performance of the HARMONI® Toric Lens N/A