Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-100
SponsorHelsinki University Central Hospital
About this trial
The purpose of this study is to assess whether endoscopic cyclophotocoagulation added to cataract surgery lowers intraocular pressure more than cataract surgery alone in patients with normal tension glaucoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed Informed Consent
Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle
Glaucoma stable with current medication assessed by a glaucoma specialist
Clinically significant cataract
Disqualifiers
Secondary Glaucoma e.g. due to previous injury or uveitis
Exfoliation syndrome
Pigment dispersion syndrome
Previous transscleral or endoscopic cyclophotocoagulation
Trial design
Design model
Parallel
Treatments tested in this trial
Phaco
Procedure/Surgeryphacoemulsification of cataract only
Phaco+ECP
Procedure/SurgeryEndoscopic cyclophotocoagulation is done in the same procedure as phacoemulsification of cataract
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PhacoActive comparator 1 intervention
Group B: Phaco+ECPExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Succes rate
Success: Decrease in Intraocular Pressure (IOP) of 20 % or more or former level with fewer medications
Time frame
One year postoperativelySecondary outcomes
1
Additional surgery
Comparison of the need for additional glaucoma surgery
Time frame
Five years postoperativelySponsors and contacts
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Source ClinicalTrials.gov