Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

Aphakia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829122
• Other study ID #: XinyuG
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Changzhou Second People's Hospital affiliated with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphakia
• Mydriasis

Intervention

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.

Locations

Country	Name	City	State
China	Preoperatively and 6 Months Postoperatively	Changzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Changzhou Second People's Hospital affiliated with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	best corrected visual acuity	logMAR	preoperatively
Primary	best corrected visual acuity	logMAR	6 months postoperatively
Primary	intraocular pressure	mmHg	preoperatively
Primary	intraocular pressure	mmHg	6 months postoperatively
Primary	pupil diameter	mm	preoperatively
Primary	pupil diameter	mm	6 months postoperatively
Primary	corneal endothelial cell count	cell/mm2	preoperatively
Primary	corneal endothelial cell count	cell/mm2	6 months postoperatively