NCT07283614

Ocular Hypotony and Refractive Predictability in RRD Surgery

Impact of Preoperative Ocular Hypotony on Refractive Predictability After Phacovitrectomy for Rhegmatogenous Retinal Detachment

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Kazakh Eye Research Institute · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates how preoperative ocular hypotony (Goldmann IOP ≤ 7 mmHg) affects refractive predictability, axial length measurements, and visual outcomes in patients undergoing combined phacovitrectomy with silicone oil for rhegmatogenous retinal detachment.

Detailed description

This observational cohort study is designed to evaluate the impact of preoperative ocular hypotony (defined as Goldmann IOP ≤ 7 mmHg) on refractive outcomes, biometry parameters, and visual acuity after combined phacovitrectomy for RRD. All included eyes undergo standard 25-gauge pars plana vitrectomy with cataract extraction with IOL implantation, endolaser photocoagulation, and silicone oil tamponade. The study population consists of eyes with primary RRD and stratified into two cohorts according to preoperative IOP: Hypotony group - eyes with Goldmann IOP ≤ 7 mmHg; Control group - eyes with normal preoperative IOP .

Conditions

• Rhegmatogenous Retinal Detachment
• Hypotony Ocular

Interventions

Type	Name	Description
PROCEDURE	Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade	Standardized single-stage clear corneal phacoemulsification with IOL implantation is combined with three-port 25-gauge pars plana vitrectomy, fluid-air exchange, endolaser photocoagulation, and silicone oil tamponade for rhegmatogenous retinal detachment. After cataract extraction and IOL placement, pars plana vitrectomy is performed with fluid-air exchange to reattach the retina, endolaser photocoagulation around retinal breaks, and tamponade with silicone oil.
PROCEDURE	Silicone Oil Removal	Silicone oil removal is performed approximately 3 months after the initial combined phacovitrectomy. Three-port 25-gauge pars plana access and pressure-controlled fluid-silicone exchange with balanced salt solution to completely remove silicone oil from the vitreous cavity. At the end of surgery, sclerotomies are sutured.

Timeline

• Start date: 2025-12-08
• Primary completion: 2026-08-31
• Completion: 2026-10-17
• First posted: 2025-12-16
• Last updated: 2026-03-18

Locations

1 site across 1 country: Kazakhstan