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

Credit Valley EyeCare

Status: Completed

Conditions: Glaucoma

Treatments: Procedure: Endoscopic Cycloplasty (ECPL); Procedure: Phacoemulsification

Study type: Interventional

Funder types: Industry

Identifiers

NCT02049333

ECPLateau10.1

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Phacoemulsification

Active Comparator group

Description:

Cataract extraction alone

Treatment:

Procedure: Phacoemulsification

Phacoemulsification with Endoscopic Cycloplasty (ECPL)

Experimental group

Description:

Cataract extraction combined with endoscopic cycloplasty

Treatment:

Procedure: Endoscopic Cycloplasty (ECPL)

Procedure: Phacoemulsification