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RecruitingNCT05829122Updated Apr 25, 2023

Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

An interventional study of Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty in Aphakia and Mydriasis, sponsored by Changzhou Second People's Hospital affiliated with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Changzhou Second People's Hospital affiliated with Nanjing Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Registered 3 years 2 months after the study started (first participant enrolled Jan 2020, registered Mar 2023).
  • Started Jan 2020; still recruiting 6 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Aphakia
  • Mydriasis

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Keywords

  • Aphakia
  • Mydriasis
03

In context

Aphakia

69 studies on the registry are indexed under Aphakia; 6 are open to participants now.

This study's planned enrollment of 20 is below the median of 103 across 52 interventional studies indexed under Aphakia.

Browse Aphakia studies →

Lead sponsor

Changzhou Second People's Hospital affiliated with Nanjing Medical University is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

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

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

Interventions

  • ProcedureSutureless 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.

06

What researchers measure

Primary outcomes

  1. best corrected visual acuity

    logMAR

    Time frame: preoperatively

  2. best corrected visual acuity

    logMAR

    Time frame: 6 months postoperatively

  3. intraocular pressure

    mmHg

    Time frame: preoperatively

  4. intraocular pressure

    mmHg

    Time frame: 6 months postoperatively

  5. pupil diameter

    mm

    Time frame: preoperatively

  6. pupil diameter

    mm

    Time frame: 6 months postoperatively

  7. corneal endothelial cell count

    cell/mm2

    Time frame: preoperatively

  8. corneal endothelial cell count

    cell/mm2

    Time frame: 6 months postoperatively

07

Study locations

1 of 1 sites recruiting
  • Preoperatively and 6 Months Postoperatively
    Changzhou, Jiangsu 213000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05829122
Lead sponsor
Changzhou Second People's Hospital affiliated with Nanjing Medical University
Responsible party
Sponsor
First posted
Apr 25, 2023
Start date
Jan 1, 2020
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Apr 25, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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