Efficacy and Safety of Lens Extraction in Patients With Pseudoexfoliation Glaucoma
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|ClinicalTrials.gov Identifier: NCT03494465|
Recruitment Status : Not yet recruiting
First Posted : April 11, 2018
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pseudoexfoliation Glaucoma Intraocular Pressure||Procedure: PHACOEMULSIFICATION Drug: MEDICAL GLAUCOMA TREATMENT||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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.
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"
- INTRAOCULAR PRESSURE [ Time Frame: 12 months ]The primary outcome will be the intraocular pressure (IOP) reduction 12 months after randomisation
- VISUAL FIELD INDEX [ Time Frame: 12 months ]Visual field (VF) progression according to the global VF index (VFI) at 12 months
- 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
- 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
- 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.
- 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.)
- 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.
- 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
- 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
- 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.