Cataract Surgery vs Cataract Surgery With ECPL for Treatment of Plateau Iris Configuration or Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to assess and compare the mechanical angle opening in patients with angle closure due to a plateau iris configuration (elevated iris) using phacoemulsification combined with endoscopic cycloplasty versus treatment with phacoemulsification alone.

Official Title
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Phacoemulsification Versus Phacoemulsification With Endoscopic Cycloplasty (ECPL) for Treatment of Plateau Iris Configuration or Syndrome: A Prospective Randomized Clinical and Surgical Study

Conditions
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Glaucoma

Intervention / Treatment
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* Procedure: Phacoemulsification
* Procedure: Endoscopic Cycloplasty (ECPL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has to be ≥ 18 years of age of either gender Nuclear sclerotic cataract graded by LOCS III to be < 5 Diagnosis of Plateau Iris Configuration or Syndrome No contraindication for cataract or ECPL operation Written informed consent on IRB approved Informed Consent Form Exclusion Criteria: Hard cataracts, LOCS III 5 and 6 Ciliary body cysts Clinically significant sequelae from trauma in which angle anatomy/physiology may have been compromised (e.g., chemical burns, significant angle recession, blunt trauma, etc.) Congenital anomaly of the irido-trabecular angle Previous intraocular surgery Previous laser gonioplasty to either eye Placement of the intraocular lens in any place other than the capsular bag Pupilloplasty Rubeosis Peripheral anterior synechiae (PAS) nasal angle and/or >180 degrees of PAS Neovascular glaucoma; or glaucoma associated with vascular ischemic disorders Active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis) Corneal opacities or disorders that would inhibit visualization of the nasal angle Chronic ocular inflammatory disease or presence of active ocular inflammation with risk for synechial/proliferative changes Inability to attend regular follow-up assessment or to give informed written consent.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phacoemulsification<br>Cataract extraction alone | Procedure: Phacoemulsification<br> <br> |
| Experimental: Phacoemulsification with Endoscopic Cycloplasty (ECPL)<br>Cataract extraction combined with endoscopic cycloplasty | Procedure: Phacoemulsification<br> <br> Procedure: Endoscopic Cycloplasty (ECPL)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Angle Depth (nasal angle) | Anterior chamber angle depth (nasal angle) measured using the Shaffer grading system and via anterior segment imaging | Twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of glaucoma medications | The number of glaucoma medications will be recorded and compared to pre-operative number of glaucoma medications. | Twelve months post-op | 
| Intraocular pressure (IOP) | IOP will be recorded and compared to pre-operative IOP. | Twelve months post-op |