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Cataract Surgery in Patients With Pseudoexfoliation and Pseudoexfoliation Glaucoma (PHACOPXG)

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ClinicalTrials.gov Identifier: NCT04590651
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Peeter Kuddu, Helsinki University Central Hospital

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.

Condition or disease Intervention/treatment Phase
Pseudoexfoliation Pseudoexfoliation Syndrome Pseudoexfoliation Glaucoma Cataract Procedure: Cataract surgery Procedure: Cataract surgery with extra anterior chamber angle aspiration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of two groups in parallel for the duration of the study
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Cataract Surgery in Patients With Pseudoexfoliation and Pseudoexfoliation Glaucoma
Actual Study Start Date : September 11, 2020
Estimated Primary Completion Date : June 11, 2023
Estimated Study Completion Date : December 11, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

Arm Intervention/treatment
Experimental: Standard PHACO cataract surgery
In this group normal phacoemulsification cataract surgery will be preformed.
Procedure: Cataract surgery
Routine phacoemulsification cataract surgery using the Alcon Centurion® device.
Other Name: Phacoemulsification

Experimental: PHACO + extra aspiration
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
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.
Other Name: Phacoemulsification with extra anterior chamber angle aspiration




Primary Outcome Measures :
  1. IOP Change [ Time Frame: IOP will be measured preoperatively and at 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years postoperatively. ]
    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.


Secondary Outcome Measures :
  1. Visual acuity change [ Time Frame: Preoperative and at 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years postoperatively. ]
    Uncorrected and best corrected visual acuity will be documented during every visit using the Snellen visual acuity chart. Change from baseline is being measured at these specified times.


Other Outcome Measures:
  1. Inflammation change [ Time Frame: Measured preoperatively and at 1 day, 1 week, 1 month, 6 months and 1 year postoperatively. ]
    Measured with the the Kona FM-600 flare meter. Photon count per millisecond. Change from baseline is being measured at these specified times.

  2. Cell density change [ Time Frame: Measured preoperatively and 1 year after surgery ]
    Endothelial cell density measured with the Konan CellChek specular microscope. Cell count per mm2. Change from baseline is being measured at these specified times.

  3. Central retinal thickness change [ Time Frame: Preoperatively and at 1 month postoperatively. ]
    Central retinal thickness is measured by the Hidelberg Spectralis OCT. Measured in micrometers. The distance between the pigment epithelium and internal limiting membrane. Change from baseline is being measured at these specified times.

  4. ONH-OCT change [ Time Frame: Measured preoperatively and at 1 month, 6 months, 1 year, 2 years and 3 years postoperatively. ]
    Ocular nerve head OCT. Measured with the Heidelberg Spectralis OCT. Possible thinning of the nerve fiber layer determined by a glaucoma specialist (NL). Change from baseline is being measured at these specified times.

  5. Visual Field change [ Time Frame: Measured 1 month, 1 year, 2 years and 3 years postoperatively. ]
    Visual Field measured with Haag-Streit Octopus static perimeter. The G program is used. Change from baseline is being measured at these specified times.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590651


Contacts
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Contact: Peeter Kuddu, MD +358401631686 peeter.kuddu@hus.fi
Contact: Kari Krootila, AP kari.krootila@hus.fi

Locations
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Finland
Helsinki University Central Hospital Recruiting
Helsinki, Uusimaa, Finland, 00160
Sub-Investigator: Peeter Kuddu, MD         
Principal Investigator: Kari Krootila, AP         
Sponsors and Collaborators
Peeter Kuddu
Investigators
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Principal Investigator: Kari Krootila, AP Helsinki University Central Hospital
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Responsible Party: Peeter Kuddu, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04590651    
Other Study ID Numbers: PHACOPXG
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Cataract
Exfoliation Syndrome
Ocular Hypertension
Eye Diseases
Lens Diseases
Iris Diseases
Uveal Diseases