The China Laser and Surgery Study : A Mixed Methods Study With an Random Control Trial Comparing Outcomes From Selective Laser Trabeculoplasty Versus Surgical Treatment (Trabeculectomy) for Glaucoma in Rural China .

NCT02955849 EARLY_PHASE1 COMPLETED

Aims and Objectives (Quantitative) Aim: To compare the effectiveness of selective laser trabeculoplasty with trabeculoplasty in lowering the intraocular pressure in patients with medically uncontrolled open angle glaucoma in rural China, taking into account the impact of patient acceptance of each type of treatment Hypothesis: Mean intraocular pressure after treatment with selective laser trabeculoplasty will be lower than with surgery due to higher acceptance rates among patients randomized to receive this treatment and therefore treatment provided at an earlier stage of disease progression.

Details

Lead sponsor	Sun Yat-sen University
Phase	EARLY_PHASE1
Status	COMPLETED
Enrolment	200
Start date	2016-09
Completion	2019-12

Conditions

• Glaucoma

Interventions

• SLT laser

Primary outcomes

• Intraocular pressure — 12 months
  * intraocular pressure in study eye 12 months after receiving treatment (laser or surgery) * the intraocular pressure of patients refusing their allocated intervention will still be recorded at 12 months post-refusal and will be considered in the analysis * patients accepting the allocated treatment \> 3 months after initial offer of treatment will be considered as having refused and their outcome intraocular pressure will be the last reading prior to treatment

Countries

China