Ocular Hypotony and Refractive Predictability in RRD Surgery

NCT07283614 | Active Not Recruiting DMC

• 1 other identifier: IRB-194-2024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhegmatogenous Retinal Detachment; Hypotony Ocular

Keywords

Rhegmatogenous Retinal Detachment; Hypotony Ocular; cataract surgery; intraocular lens calculation; refractive assessment; vitreoretinal surgery

Outcome Measures

Primary Outcomes (1)

• Mean Absolute Error (MAE) of Postoperative Refraction

  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.

  1 month after silicone oil removal

Secondary Outcomes (2)

• Axial Length Measurement

  1 month after silicone oil removal

• Best-Corrected Visual Acuity

  3 months after combined surgery, 1 month after silicone oil removal

Study Arms (2)

RRD Patients with Ocular Hypotony

ACTIVE COMPARATOR

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.

Procedure: Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade; Procedure: Silicone Oil Removal

RRD patients with normal IOP

ACTIVE COMPARATOR

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.

Procedure: Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade; Procedure: Silicone Oil Removal

Interventions

Silicone Oil Removal PROCEDURE

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.

RRD Patients with Ocular Hypotony; RRD patients with normal IOP

Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade PROCEDURE

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.

RRD Patients with Ocular Hypotony; RRD patients with normal IOP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kazakh Eye Research Institute: lead

Study Sites (1)

Kazakh Eye Research Institute

Almaty, 050012, Kazakhstan

Location

MeSH Terms

Conditions

Ocular Hypotension

Interventions

Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 16, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 17, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

KA (1)