Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty

Study Overview
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Brief Summary
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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.

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

Conditions
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Aphakia, Mydriasis

Intervention / Treatment
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* Procedure: Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty<br> | Procedure: Sutureless Intrascleral Intraocular Lens Fixation and Modified Iris Cerclage Pupilloplasty<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aphakia, Mydriasis