Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

Sponsor

Changzhou Second People's Hospital affiliated with Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05829122

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aphakia Mydriasis	Procedure: Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

best corrected visual acuity [preoperatively]
logMAR
best corrected visual acuity [6 months postoperatively]
logMAR
intraocular pressure [preoperatively]
mmHg
intraocular pressure [6 months postoperatively]
mmHg
pupil diameter [preoperatively]
mm
pupil diameter [6 months postoperatively]
mm
corneal endothelial cell count [preoperatively]
cell/mm2
corneal endothelial cell count [6 months postoperatively]
cell/mm2

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Preoperatively and 6 Months Postoperatively	Changzhou	Jiangsu	China	213000

Sponsors and Collaborators

Changzhou Second People's Hospital affiliated with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Changzhou Second People's Hospital affiliated with Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT05829122

Other Study ID Numbers:

XinyuG

First Posted:

Apr 25, 2023

Last Update Posted:

Apr 25, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Changzhou Second People's Hospital affiliated with Nanjing Medical University

Aphakia

Mydriasis

Additional relevant MeSH terms:

Aphakia

Mydriasis

Study Results

No Results Posted as of Apr 25, 2023