Cataract Surgery in Patients With Pseudoexfoliation and Pseudoexfoliation Glaucoma

NCT04590651 | Unknown

• 1 other identifier: PHACOPXG
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to document the effect cataract surgery has on the pseudoexfoliation and pseudoexfoliation glaucoma eye. Details such has patient history, history of possible glaucoma, intraocular pressure, status of the eye, operation parameters and postoperative effect will be documented. The study is prospective and randomised . Patients will be divided in to two groups: in one standard phacoemulsification cataract surgery will be preformed. In the second group the anterior chamber angel will be aspirated an extra minute at the end of the case with the IA probe. The aim is to determine weather this extra aspiration will have an effect on postoperative intraocular pressure and other parameters.

Conditions

Pseudoexfoliation; Pseudoexfoliation Syndrome; Pseudoexfoliation Glaucoma; Cataract

Outcome Measures

Primary Outcomes (1)

• IOP Change

  Intraocular pressure (IOP) measured twice during every visit with a Goldmann applanation. tonometer. Measurements will be taken before 12 p.m local time. Change from baseline is being measured at these specified times.

  IOP will be measured preoperatively and at 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years postoperatively.

Secondary Outcomes (1)

• Visual acuity change

  Preoperative and at 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years postoperatively.

Other Outcomes (5)

• Inflammation change

  Measured preoperatively and at 1 day, 1 week, 1 month, 6 months and 1 year postoperatively.

• Cell density change

  Measured preoperatively and 1 year after surgery

• Central retinal thickness change

  Preoperatively and at 1 month postoperatively.

Study Arms (2)

Standard PHACO cataract surgery

EXPERIMENTAL

In this group normal phacoemulsification cataract surgery will be preformed.

Procedure: Cataract surgery

PHACO + extra aspiration

EXPERIMENTAL

In this group an extra one minute anterior chamber angle aspiration will be preformed at the end of a standard cataract operation.

Procedure: Cataract surgery with extra anterior chamber angle aspiration

Interventions

Cataract surgery PROCEDURE

Routine phacoemulsification cataract surgery using the Alcon Centurion® device.

Also known as: Phacoemulsification

Standard PHACO cataract surgery

Cataract surgery with extra anterior chamber angle aspiration PROCEDURE

Routine phacoemulsification cataract surgery using the Alcon Centurion® device. At the end of the case a one minute extra anterior chamber angle aspiration will be preformed after the removal of the viscoelastic agent.

Also known as: Phacoemulsification with extra anterior chamber angle aspiration

PHACO + extra aspiration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has to meet the criteria set by the Helsinki Central University hospital for cataract surgery: best corrected visual acuity of 0,5 (Snellen) or below in the better eye or 0,3 (Snellen) or below in the worse eye; glare or other debilitating symptoms determined to be caused by cataract; cataract interfering with the diagnosis or follow up of glaucoma
• Pseudoexfoliation or pseudoexfoliation glaucoma

You may not qualify if:

• Previous intraocular surgery of any kind
• Previous glaucoma surgery or cyclophotocoagulation
• Previous selective laser trabeculoplasty (SLT) or argon laser trabeculoplasty (ALT)
• Any other ocular pathology likely to demand surgery during the course of the study
• Wet age related macular degeneration (wetAMD)
• Need for glaucoma surgery determined by a glaucoma specialist in cases where the intraocular pressure is deemed to high compared to the ocular nerve head condition and/or visual field defect.
• History of uveitis.
• History of herpetic keratitis.
• History of ocular trauma.
• Dementia or other conditions preventing the patient from adhering to the study protocol.

Sponsors & Collaborators

• Peeter Kuddu: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Uusimaa, 00160, Finland

Location

MeSH Terms

Conditions

Exfoliation Syndrome; Cataract

Interventions

Cataract Extraction; Phacoemulsification

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Kari Krootila, AP

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patient will not know which group he or she has been randomised to during the duration of the study. The care provider and investigator will not know the randomisation before the patient is enrolled in the study. The care provider and investigator will know the randomisation group at the time of randomisation, which will take place after the preoperative data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 19, 2020
• Study Start: September 11, 2020
• Primary Completion: June 11, 2023
• Study Completion: December 11, 2023
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the conclusion of the study for 2 years
• Access Criteria: Access granted for healthcare professionals, investigators and the peer-review process.

Locations

FI (1)