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Impact of Capsular Tension Ring Implantation on Intraocular Lens Position

Primary Purpose

Cataract, High Myopia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
phacoemulsification combined with IOL and CTR implantation
phacoemulsification combined with IOL implantation
Sponsored by
Xuhua Tan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IOL plus CTR Patients will undergo phacoemulsification combined with IOL and CTR implantation.

single IOL Patients will undergo phacoemulsification combined with IOL implantation.

Arm Description

Outcomes

Primary Outcome Measures

IOL dencentration
Measured by anterior segment OCT (CASIA2)

Secondary Outcome Measures

IOL dencentration
Measured by anterior segment OCT (CASIA2)
IOL tilt
Measured by anterior segment OCT (CASIA2)
Anterior capsule contraction
Compare the area of anterior capsule opening recorded by slit lamp photograph and analyzed by Image J software.
Posterior capsule attachment with IOL
Measured by anterior segment OCT (CASIA2) and analyzed by Image J software.
Posterior capsular opacification
Recorded by slit lamp photograph and analyzed by EPCO2000 analysis software.
BCVA
BCVA is evaluated with ETDRS visual acuity chart.
Optical quality
Measured by OPD-SCAN III.
Visual function
Measured by visual function assessment questionnaires.

Full Information

First Posted
December 2, 2021
Last Updated
April 17, 2023
Sponsor
Xuhua Tan
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1. Study Identification

Unique Protocol Identification Number
NCT05161520
Brief Title
Impact of Capsular Tension Ring Implantation on Intraocular Lens Position
Official Title
Impact of Capsular Tension Ring Implantation on Intraocular Lens Tilt and Decentration in Cataract Patients With High Myopia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xuhua Tan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, High Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IOL plus CTR Patients will undergo phacoemulsification combined with IOL and CTR implantation.
Arm Type
Active Comparator
Arm Title
single IOL Patients will undergo phacoemulsification combined with IOL implantation.
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification combined with IOL and CTR implantation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification combined with IOL implantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
IOL dencentration
Description
Measured by anterior segment OCT (CASIA2)
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
IOL dencentration
Description
Measured by anterior segment OCT (CASIA2)
Time Frame
Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery
Title
IOL tilt
Description
Measured by anterior segment OCT (CASIA2)
Time Frame
Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery
Title
Anterior capsule contraction
Description
Compare the area of anterior capsule opening recorded by slit lamp photograph and analyzed by Image J software.
Time Frame
Baseline, 1 week, 1 month, 3 months, 6 months, 1 year after surgery
Title
Posterior capsule attachment with IOL
Description
Measured by anterior segment OCT (CASIA2) and analyzed by Image J software.
Time Frame
1 week, 1 month, 3 months, 6 months, 1 year after surgery
Title
Posterior capsular opacification
Description
Recorded by slit lamp photograph and analyzed by EPCO2000 analysis software.
Time Frame
1 week, 1 month, 3 months, 6 months, 1 year after surgery
Title
BCVA
Description
BCVA is evaluated with ETDRS visual acuity chart.
Time Frame
Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery
Title
Optical quality
Description
Measured by OPD-SCAN III.
Time Frame
Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery
Title
Visual function
Description
Measured by visual function assessment questionnaires.
Time Frame
3 months, 6 months, 1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 years old; axis length≥26mm; Visually significant cataract; The patient is willing and able to complete all necessary follow-ups and examinations. Exclusion Criteria: Intraoperative or postoperative complications: such as intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, endophthalmitis, etc.; Other ocular comorbidity: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.; History of intraocular surgery; Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.; Any condition that the study physician considers to be an impediment to the clinical trial.
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuhua Tan, PhD
Phone
+86-13926019722
Email
doctxh@163.com
First Name & Middle Initial & Last Name & Degree
Haowen Lin, Master
Phone
+86-13275000978
Email
962773724@qq.com

12. IPD Sharing Statement

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Impact of Capsular Tension Ring Implantation on Intraocular Lens Position

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