Hypotony Ocular, Rhegmatogenous Retinal Detachment
Conditions
Keywords
Rhegmatogenous Retinal Detachment, Hypotony Ocular, cataract surgery, intraocular lens calculation, refractive assessment, vitreoretinal surgery
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 .
Interventions
PROCEDURECombined 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.
PROCEDURESilicone 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.
Sponsors
Kazakh Eye Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Error (MAE) of Postoperative Refraction | 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
| Measure | Time frame | Description |
|---|---|---|
| Axial Length Measurement | 1 month after silicone oil removal | Difference between preoperative and postoperative axial length measurements, and its correlation with preoperative IOP status. |
| Best-Corrected Visual Acuity | 3 months after combined surgery, 1 month after silicone oil removal | Best-Corrected Visual Acuity measured in Logarithm of the Minimum Angle of Resolution (LogMAR) units using standard visual acuity charts and compared between hypotony and normotony groups after surgery and silicone oil removal |
Countries
Kazakhstan
Outcome results
None listed