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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02049333

Enrollment

Registered

2014-01-30

Start date

2010-11-30

Completion date

2013-11-30

Last updated

2014-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Brief summary

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.

Interventions

PROCEDUREPhacoemulsification

PROCEDUREEndoscopic Cycloplasty (ECPL)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
Intra- and post-operative complications	Up to one year after surgery	Analyzing any unexpected complications from the surgery such as prolonged hypotony, intraocular pressure spike, prolonged corneal inflammation etc. This will be done during the clinic visit and analyzed under slit lamp examination.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026