NCT05829122

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 25, 2023

Status Verified

March 1, 2023

Enrollment Period

3.9 years

First QC Date

March 30, 2023

Last Update Submit

April 12, 2023

Conditions

AphakiaMydriasis

Keywords

AphakiaMydriasis

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (1)

Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

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

Interventions

Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage PupilloplastyPROCEDURE

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.

Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of aphakia
  • permanently dilated pupils
  • history of phacoemulsification and pars plana vitrectomy surgeries for lens dislocation after blunt trauma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Preoperatively and 6 Months Postoperatively

Changzhou, Jiangsu, 213000, China

RECRUITING

MeSH Terms

Conditions

AphakiaMydriasis

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesPupil Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 25, 2023

Study Start

January 1, 2020

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

April 25, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)