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Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

Primary Purpose

Aphakia, Mydriasis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty
Sponsored by
Changzhou Second People's Hospital affiliated with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphakia focused on measuring Aphakia, Mydriasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnosis of aphakia permanently dilated pupils history of phacoemulsification and pars plana vitrectomy surgeries for lens dislocation after blunt trauma Exclusion Criteria: iris defects severe diseases such as cyclodialysis cleft, uncontrolled IOP, retinal detachment poorly controlled systemic diseases such as diabetes and hypertension corneal endothelial cell counts of <1000/mm2 <6 months of follow-up

Sites / Locations

  • Preoperatively and 6 Months PostoperativelyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

Arm Description

Outcomes

Primary Outcome Measures

best corrected visual acuity
logMAR
best corrected visual acuity
logMAR
intraocular pressure
mmHg
intraocular pressure
mmHg
pupil diameter
mm
pupil diameter
mm
corneal endothelial cell count
cell/mm2
corneal endothelial cell count
cell/mm2

Secondary Outcome Measures

Full Information

First Posted
March 30, 2023
Last Updated
April 12, 2023
Sponsor
Changzhou Second People's Hospital affiliated with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05829122
Brief Title
Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty
Official Title
Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty for Aphakia and Traumatic Mydriasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changzhou Second People's Hospital affiliated with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, patients with various causes of pupillary dilatation were recruited, and medical records and ophthalmology examinations, including slit-lamp examination, visual acuity, best corrected visual acuity, intraocular pressure, pupil diameter, corneal endothelial cell count, fundus examination, and photophobia score, were collected. Those who met the recruitment criteria underwent modified iris cerclage pupilloplasty. The modified iris cerclage pupilloplasty was performed by making four clear corneal incisions, suturing the iris 3-4 times consecutively between each two incisions, completing 360 degrees of iris suturing in sequence, and finally tying the knot intraocularly to complete the iris cerclage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Mydriasis
Keywords
Aphakia, Mydriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty
Intervention Description
In this study, patients with various causes of pupillary dilatation were recruited, and medical records and ophthalmology examinations, including slit-lamp examination, visual acuity, corrected visual acuity, intraocular pressure, pupil diameter, pupil area, corneal endothelial cell count fundus examination, and photophobia score, were collected. Those who met the recruitment criteria underwent modified iris cerclage. The modified iris cerclage was performed by making four clear corneal incisions, suturing the iris 3-4 times consecutively between each two incisions, completing 360 degrees of iris suturing in sequence, and finally tying the knot intraocularly to complete the iris cerclage.
Primary Outcome Measure Information:
Title
best corrected visual acuity
Description
logMAR
Time Frame
preoperatively
Title
best corrected visual acuity
Description
logMAR
Time Frame
6 months postoperatively
Title
intraocular pressure
Description
mmHg
Time Frame
preoperatively
Title
intraocular pressure
Description
mmHg
Time Frame
6 months postoperatively
Title
pupil diameter
Description
mm
Time Frame
preoperatively
Title
pupil diameter
Description
mm
Time Frame
6 months postoperatively
Title
corneal endothelial cell count
Description
cell/mm2
Time Frame
preoperatively
Title
corneal endothelial cell count
Description
cell/mm2
Time Frame
6 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of aphakia permanently dilated pupils history of phacoemulsification and pars plana vitrectomy surgeries for lens dislocation after blunt trauma Exclusion Criteria: iris defects severe diseases such as cyclodialysis cleft, uncontrolled IOP, retinal detachment poorly controlled systemic diseases such as diabetes and hypertension corneal endothelial cell counts of <1000/mm2 <6 months of follow-up
Facility Information:
Facility Name
Preoperatively and 6 Months Postoperatively
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xincheng Sun
Phone
+8613861215676
Email
czeyedoctor@stu.njmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

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