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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049333
• Other study ID #: ECPLateau10.1
• Status: Completed
• Phase: N/A
• First received: January 27, 2014
• Last updated: January 29, 2014
• Start date: November 2010
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Credit Valley EyeCare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Food & Drug Act & Regulations
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Phacoemulsification

• Endoscopic Cycloplasty (ECPL)

Locations

Country	Name	City	State
Canada	Osler EyeCare	Brampton	Ontario
Canada	Credit Valley EyeCare	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Credit Valley EyeCare

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intra- and post-operative complications	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.	Up to one year after surgery	Yes
Primary	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	No
Secondary	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	No
Secondary	Intraocular pressure (IOP)	IOP will be recorded and compared to pre-operative IOP.	Twelve months post-op	No