Impact of Preoperative Ocular Hypotony on Refractive Predictability After Phacovitrectomy for Rhegmatogenous Retinal Detachment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Mean Absolute Error (MAE) of Postoperative Refraction
Study Overview
Brief 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 .
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of primary rhegmatogenous retinal detachment (RRD)
- •Single-stage combined phacovitrectomy with clear corneal phacoemulsification with IOL implantation and 25G pars plana vitrectomy with silicone oil tamponade in the study eye
- •Preoperative intraocular pressure (IOP) in the study eye measured by Goldmann applanation tonometry: Hypotony group: IOP ≤ 7 mmHg; Normotony group: IOP > 7 mmHg
- •Planned silicone oil removal approximately 3 months after the initial combined surgery and ability to attend follow-up for refractive assessment 1 month after silicone oil removal
- •Age (e.g., ≥18 years) and ability to provide informed consent
Exclusion Criteria
- •Previous intraocular surgery in the study eye
- •Secondary or complex RRD associated with ocular trauma, uveitis or other active intraocular inflammation, proliferative diabetic retinopathy or other advanced vascular retinopathies, significant ocular malformations or congenital anomalies of the globe or posterior segment, pre-existing advanced glaucoma or uncontrolled ocular hypertension, or other optic nerve pathology that could confound visual and refractive outcomes, corneal opacity, significant corneal irregularity, or media opacity precluding reliable biometry or accurate axial length measurement in the study eye, systemic diseases or autoimmune conditions with known ocular involvement that may affect the retina, choroid, or refraction
Arms & Interventions
RRD Patients with Ocular Hypotony
Patients with primary rhegmatogenous retinal detachment (RRD) and preoperative ocular hypotony, defined as Goldmann intraocular pressure (IOP) ≤ 7 mmHg, undergoing combined phacoemulsification and IOL implantation, pars plana vitrectomy with silicone oil tamponade.
Silicone oil is planned to be removed approximately 3 months after the initial combined surgery and detailed refractive assessment is performed 1 month after silicone oil removal. This cohort is used to evaluate the impact of preoperative hypotony on axial length measurements, refractive predictability (MAE, % within ±0.50 D), and visual outcomes.
Intervention: Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade (Procedure)
RRD Patients with Ocular Hypotony
Patients with primary rhegmatogenous retinal detachment (RRD) and preoperative ocular hypotony, defined as Goldmann intraocular pressure (IOP) ≤ 7 mmHg, undergoing combined phacoemulsification and IOL implantation, pars plana vitrectomy with silicone oil tamponade.
Silicone oil is planned to be removed approximately 3 months after the initial combined surgery and detailed refractive assessment is performed 1 month after silicone oil removal. This cohort is used to evaluate the impact of preoperative hypotony on axial length measurements, refractive predictability (MAE, % within ±0.50 D), and visual outcomes.
Intervention: Silicone Oil Removal (Procedure)
RRD patients with normal IOP
Patients with primary rhegmatogenous retinal detachment (RRD) and normal preoperative IOP (> 7 mmHg) undergoing the same combined phacovitrectomy with IOL implantation and silicone oil tamponade.
Silicone oil is planned to be removed approximately 3 months after the initial combined surgery and detailed refractive assessment is performed 1 month after silicone oil removal. This cohort serves as the comparison group for the hypotony arm to determine whether normal preoperative IOP is associated with more accurate axial length measurements, better refractive predictability, and comparable or superior visual outcomes.
Intervention: Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade (Procedure)
RRD patients with normal IOP
Patients with primary rhegmatogenous retinal detachment (RRD) and normal preoperative IOP (> 7 mmHg) undergoing the same combined phacovitrectomy with IOL implantation and silicone oil tamponade.
Silicone oil is planned to be removed approximately 3 months after the initial combined surgery and detailed refractive assessment is performed 1 month after silicone oil removal. This cohort serves as the comparison group for the hypotony arm to determine whether normal preoperative IOP is associated with more accurate axial length measurements, better refractive predictability, and comparable or superior visual outcomes.
Intervention: Silicone Oil Removal (Procedure)
Outcomes
Primary Outcomes
Mean Absolute Error (MAE) of Postoperative Refraction
Time Frame: 1 month after silicone oil removal
Mean Absolute Error between the target refraction predicted by preoperative IOL power calculation and the achieved postoperative spherical equivalent refraction, calculated in diopters for each eye. Percentage of eyes in each group with an Mean Absolute Error ≤ ±0.50 diopters between the target refraction and the achieved postoperative spherical equivalent refraction.
Secondary Outcomes
- Best-Corrected Visual Acuity(3 months after combined surgery, 1 month after silicone oil removal)
- Axial Length Measurement(1 month after silicone oil removal)
Investigators
Kairat Ruslanuly
Principal Investigator
Kazakh Eye Research Institute