Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

Not Applicable

Recruiting

• Conditions: Mydriasis; Aphakia
• Interventions: Procedure: Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

• Registration Number: NCT05829122
• Lead Sponsor: Changzhou Second People's Hospital affiliated with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-04-12
• Last Update Submitted: 2023-04-12
• Study First Posted: 2023-04-25
• Last Update Posted: 2023-04-25
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty	Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty	-

Primary Outcome Measures

Name	Time	Method
intraocular pressure	6 months postoperatively	mmHg
pupil diameter	6 months postoperatively	mm
best corrected visual acuity	6 months postoperatively	logMAR
corneal endothelial cell count	6 months postoperatively	cell/mm2

Trial Locations

Locations (1)

Preoperatively and 6 Months Postoperatively; 🇨🇳 Changzhou, Jiangsu, China