Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Lens Extraction in Patients With Pseudoexfoliation Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494465
Recruitment Status : Not yet recruiting
First Posted : April 11, 2018
Last Update Posted : April 18, 2018
Sponsor:
Collaborators:
M.J. López-Valladares, PhD, University Hospital Complex of Santiago de Compostela, Spain
A.Azuara-Blanco, PhD, Centre for Public Health, Queen's University Belfast, UK
Information provided by (Responsible Party):
SARA POSE BAZARRA, Xerencia de Xestión Integrada de Ferrol

Brief Summary:
There are several publications that have demonstrated the protective role of cataract surgery against the development of long-term glaucoma, especially in cases of pseudoexfoliation glaucoma (PXFG). Cataract surgery in patients with pseudoexfoliation (PXF) is a procedure with higher rates of complications due to its smaller pupillary diameter and its greater zonular weakness, so lens extraction performed earlier could possibly reduce intra and postoperative complications. Given the severity and high prevalence of PXFG in our environment, investigators proposed a randomized clinical trial to evaluate the efficacy of cataract surgery in reducing the intraocular pressure (IOP) at 12 months and thereby change the course of the disease. The control group will have glaucoma treatment according to standard practice.

Condition or disease Intervention/treatment Phase
Pseudoexfoliation Glaucoma Intraocular Pressure Procedure: PHACOEMULSIFICATION Drug: MEDICAL GLAUCOMA TREATMENT Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial to Evaluate the Efficacy and Safety of Lens Extraction in Patients With Pseudoexfoliation Glaucoma: a Feasibility and Pilot Study
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: MEDICAL TREATMENT GROUP

Medical treatment will be used in a staggered manner and may also associate laser trabeculoplasty. If necessary, then surgical treatment would be indicated: trabeculectomy. or another filtering surgery.

Inadequate IOP control will be determined by the local ophthalmologist, and additional treatment will be indicated to achieve an target IOP.

Drug: MEDICAL GLAUCOMA TREATMENT
The escalation of topical hypotensive medications will be carried out with the following sequence: 1. single topical medication; 2. double topical therapy; 3. triple topical therapy. Beginning, with the exception of individual contraindications, with prostaglandin analogs, followed by topical beta-blockers, carbonic anhydrase inhibitors and finally alpha-agonists.Target IOP will be used in both groups to inform the need of escalation of therapy; in patients with ocular hypertension the target IOP will be 21 mmHg. In patients with mild glaucoma target IOP will be 18 mmHg, and in patients with moderate glaucoma the target IOP will be 15 mmHg.

Experimental: INTERVENTION GROUP

In lens extraction arm, patients will undergo lens phacoemulsification with intraocular lens implant (IOL) within 60 days after randomization.

If additional treatment is required, the same stepped sequence of therapy described for "medical treatment group" will be used and will be considered a therapeutic failure.

Procedure: PHACOEMULSIFICATION
Standard phacoemulsification with intraocular lens implant will be perform within 60 days after allocation. If IOP target is not achieve, patients will be treated as in "medical treatment group"




Primary Outcome Measures :
  1. INTRAOCULAR PRESSURE [ Time Frame: 12 months ]
    The primary outcome will be the intraocular pressure (IOP) reduction 12 months after randomisation


Secondary Outcome Measures :
  1. VISUAL FIELD INDEX [ Time Frame: 12 months ]
    Visual field (VF) progression according to the global VF index (VFI) at 12 months

  2. RETINAL NERVE FIBER LAYER [ Time Frame: 12 months ]
    Retinal nerve fiber layer (RNFL) thickness by optical coherence tomography (OCT): investigators will compare the reduction in the retinal nerve fiber layer by OCT according to the premium analysis of glaucoma (Heidelberg) between both arms of the treatment at 12 months

  3. INCIDENCE OF GLAUCOMA SURGERY [ Time Frame: 12 months ]
    Number of trabeculectomy or filtering surgery required as a result of poor control of IOP or progression in the VF in both groups at 12 months

  4. BEST CORRECTED VISUAL ACUITY [ Time Frame: 12 months ]
    Best-corrected visual acuity (BCVA): investigators will compare the change of visual acuities (VA) between randomisation and last follow-up at 12 months.

  5. QUALITY OF LIFE [ Time Frame: 12 months ]

    Investigators will evaluate changes in quality of life before and 12 months after the intervention, using a visual function quality questionnaire: National Eye Institute Visual Function Questionnaire (NEI-VFQ25).

    Translation of the 2000 version of the National Eye Institute Visual Function Quality -25, public domain will be used. (Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD, National Eye Institute Visual Function Questionnaire Field Test Investigators, Development of the 25-item National Eye Institute Visual Function Questionnaire, Arch Ophthalmol, 2001 Jul; 119 ( 7): 1050-8.)


  6. NUMBER OF GLAUCOMA DRUGS [ Time Frame: 12 months ]
    Number of glaucoma drugs as well as the possible intolerances to it: Investigate the reduction of drugs after cataract surgery and the adverse effects of these in patients who require topical treatment. Comparison of both groups in search of better quality of life and tolerance of both treatments.

  7. COST BENEFIT ANALYSIS [ Time Frame: 12 months ]
    Through a cost-benefit analysis investigators will evaluate the common and pertinent costs in each treatment arm and evaluate the health benefit in economic terms

  8. INCIDENCE OF TREATMENT ADVERSE EVENTS [ Time Frame: 12 months ]
    Investigators will determine the safety profile of both interventions through an evaluation of intraoperative and post-treatment complications

  9. RATE OF RECRUITMENT [ Time Frame: 12 months ]
    To estimate rates of recruitment among eligible patients who are offered trial participation, and withdrawal rates to confirm the feasibility of conducting a large and definite randomized clinical trial to evaluate cataract surgery as a treatment for patients with PXFG.



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.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Presence of cataract with visual symptoms that justify the intervention, such as photophobia, difficulty in activities of daily living or driving.
  2. Mild or moderate PXF glaucoma or ocular hypertension (OHT) over 25mmHg + PXF syndrome.

    Glaucoma is defined as: reproducible defects (two or more contiguous points with a loss of P <0.01, three or more contiguous points with a loss of P <0.05 or greater) in the visual field (VF) or , ophthalmoscopically detectable damage to the optic nerve (cup disc ratio> or = 0.7 and / or focal thinning of the optic nerve rim and / or asymmetry of cup disc ratio > or = 0.2 between both eyes).

    PXF is defined clinically by the presence of pseudoexfoliative material in the anterior capsule of the lens.

    Mild glaucoma is defined as MD< 6dB. Moderate glaucoma is defined as MD < 12dB.

  3. Naive patients or without topical hypotensive treatment in the last 3 months.
  4. Age: patients > 60 years.
  5. Best corrected visual acuity (BCVA) between range > 0.4 and <0.7
  6. Signature of the specific informed consent of the study.

Exclusion criteria:

  1. Advanced glaucoma. It is defined as an average deviation > -15dB and / or threat of fixation (paracentral point with sensitivity of 0 dB), and / or cup disc ratio > 0.9
  2. Corneal edema, corneal opacity or any other known corneal factor that may increase the risk of complications during surgery
  3. Previous cataract surgery in the eye included in the study
  4. Axial length <20 mm
  5. Estimated IOL power> 30 diopters
  6. Visual acuity <0.4 or> 0.7
  7. Signs of zonular weakness: phacodonesis, iridodonesis, lens subluxation, asymmetry of anterior chamber depth
  8. Pupillary dilation <5 mm
  9. Advanced cataract

Publications:

Layout table for additonal information
Responsible Party: SARA POSE BAZARRA, Ophthalmologist, MD, Xerencia de Xestión Integrada de Ferrol
ClinicalTrials.gov Identifier: NCT03494465     History of Changes
Other Study ID Numbers: FACOPEX
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Exfoliation Syndrome
Ocular Hypertension
Eye Diseases
Iris Diseases
Uveal Diseases