Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty for Aphakia and Traumatic Mydriasis

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.

Study Overview

• Status: Recruiting
• Conditions: Aphakia; Mydriasis
• Intervention / Treatment: Procedure: Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • Recruiting
      • Preoperatively and 6 Months Postoperatively
      • Contact: Xincheng Sun; Phone Number: +8613861215676; Email: czeyedoctor@stu.njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

Procedure: Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
best corrected visual acuity	logMAR	preoperatively
best corrected visual acuity	logMAR	6 months postoperatively
intraocular pressure	mmHg	preoperatively
intraocular pressure	mmHg	6 months postoperatively
pupil diameter	mm	preoperatively
pupil diameter	mm	6 months postoperatively
corneal endothelial cell count	cell/mm2	preoperatively
corneal endothelial cell count	cell/mm2	6 months postoperatively

Collaborators and Investigators

• Sponsor: Changzhou Second People's Hospital affiliated with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Mydriasis; Aphakia
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Pupil Disorders; Aphakia; Mydriasis
• Other Study ID Numbers: XinyuG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No