Rhegmatogenous Retinal DetachmentHYP-RRDNCT07283614
Ocular Hypotony and Refractive Predictability in RRD Surgery
A study testing Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade and Silicone Oil Removal in people with Rhegmatogenous Retinal Detachment and Hypotony Ocular, run by Kazakh Eye Research Institute at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhegmatogenous Retinal Detachment, Hypotony Ocular
- What is being tested?
- Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade and Silicone Oil Removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteKazakhstan
- Study dates
- 8 Dec 2025to 17 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Preoperative Ocular Hypotony on Refractive Predictability After Phacovitrectomy for Rhegmatogenous Retinal Detachment
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.
Read the 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
- Being tested
- Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade, Silicone Oil Removal
- Keywords
- Rhegmatogenous Retinal Detachment, Hypotony Ocular, cataract surgery, intraocular lens calculation, refractive assessment, vitreoretinal surgery
- Medical subject headings
- Ocular Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil TamponadeProcedure or surgery
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.
Silicone Oil RemovalProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade; Procedure: Silicone Oil Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after silicone oil removal
Secondary outcomes (2)
Axial Length Measurement
Difference between preoperative and postoperative axial length measurements, and its correlation with preoperative IOP status.
Measured: 1 month after silicone oil removal
Best-Corrected Visual Acuity
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
Measured: 3 months after combined surgery, 1 month after silicone oil removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start8 Dec 2025
- Primary completion31 Aug 2026
- Study completion17 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kazakh Eye Research Institute
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Kairat Ruslanuly, Kazakh Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283614
- Sponsor's protocol ID
- IRB-194-2024
- Acronym
- HYP-RRD
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Ocular Hypotony on Refractive Predictability After Phacovitrectomy for Rhegmatogenous Retinal Detachment
- ClinicalTrials.gov ID
- NCT07283614
- Acronym / sponsor ID
- HYP-RRD / IRB-194-2024
- Conditions
- Rhegmatogenous Retinal Detachment, Hypotony Ocular
- Keywords
- Rhegmatogenous Retinal Detachment, Hypotony Ocular, cataract surgery, intraocular lens calculation, refractive assessment, vitreoretinal surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kazakh Eye Research InstituteResearch network
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 17 Oct 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RRD Patients with Ocular Hypotony | Active comparator | Procedure: Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade, Procedure: Silicone Oil RemovalPatients 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. |
| RRD patients with normal IOP | Active comparator | Procedure: Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade, Procedure: Silicone Oil RemovalPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil TamponadeStandardized 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 or surgery | RRD Patients with Ocular Hypotony, RRD patients with normal IOP |
| Silicone Oil RemovalSilicone 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. | Procedure or surgery | RRD Patients with Ocular Hypotony, RRD patients with normal IOP |
Primary outcome
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.
2 secondary outcomes
Axial Length Measurement
Time frame: 1 month after silicone oil removal
Best-Corrected Visual Acuity
Time frame: 3 months after combined surgery, 1 month after silicone oil removal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Phacovitrectomy with Intraocular Lens Implantation and Silicone Oil Tamponade and Silicone Oil Removal in people with Rhegmatogenous Retinal Detachment and Hypotony Ocular, run by Kazakh Eye Research Institute at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Absolute Error (MAE) of Postoperative Refraction (time frame: 1 month after silicone oil removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.