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Retinal Detachment RhegmatogenousTARSNCT07495319

Influence of Tamponade on Retinal Shift in Eyes Undergoing Vitrectomy for Rhegmatogenous Retinal Detachment: A Comparison of Gas Versus Silicone Oil in a Pakistani Population

A study testing Pars plana vitrectomy in people with Retinal Detachment Rhegmatogenous and Vitrectomy, run by Wardah at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rhegmatogenous retinal detachment (RRD) is a vision-threatening condition with an estimated incidence of approximately 1 in 10,000 individuals annually. Pars plana vitrectomy (PPV) combined with intraocular tamponade agents such as expansile gas or silicone oil is a commonly used surgical treatment for retinal… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pars plana vitrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 sitePakistan
Study dates
15 Apr 2025to 31 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

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).
  • Planned management with pars plana vitrectomy (PPV).
  • Age ≥ 18 years.
  • Willingness and ability to provide written informed consent.

Who cannot join

  • Prior vitreoretinal surgery in the study eye.
  • Tractional or exudative retinal detachment.
  • Media opacities (e.g., dense cataract, corneal opacity, vitreous hemorrhage) precluding fundus autofluorescence imaging.
  • Any condition that, in the investigator's opinion, would preclude safe participation or compliance with study procedures.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Aga Khan University Hospital

    Karachi, 74000

Other trials in Pakistan

About this study

Rhegmatogenous retinal detachment (RRD) is a vision-threatening condition with an estimated incidence of approximately 1 in 10,000 individuals annually. Pars plana vitrectomy (PPV) combined with intraocular tamponade agents such as expansile gas or silicone oil is a commonly used surgical treatment for retinal reattachment. Although anatomical success rates following PPV are high, postoperative retinal displacement has increasingly been recognized as a frequent phenomenon. Retinal displacement may lead to visual distortion, metamorphopsia, and patient dissatisfaction despite successful anatomical repair.

Fundus autofluorescence (FAF) imaging allows detection of retinal vessel printings (RVPs), which appear as hyperautofluorescent lines corresponding to the previous location of retinal vessels. These findings are considered markers of postoperative retinal displacement. Several studies have suggested that the type of intraocular tamponade may influence the occurrence of retinal displacement, with some reports demonstrating higher displacement rates in eyes treated with gas tamponade compared with silicone oil. However, findings remain inconsistent across studies, and limited data exist from South Asian populations.

Read more

This study aims to evaluate the influence of intraocular tamponade type on postoperative retinal displacement following PPV for primary rhegmatogenous retinal detachment in a Pakistani population.

This prospective randomized comparative study was conducted at the Section of Ophthalmology and Visual Sciences, Department of Surgery, Aga Khan University Hospital, Karachi, Pakistan. Patients diagnosed with primary rhegmatogenous retinal detachment who were scheduled to undergo pars plana vitrectomy were eligible for inclusion. Participants were randomized to receive either gas tamponade (sulfur hexafluoride [SF6] or perfluoropropane [C3F8]) or silicone oil tamponade at the end of surgery.

Step 1: Define the Arms

ARM 1: Gas Tamponade

ARM 2: Silicone Oil Tamponade

All surgical procedures were performed using a standardized 25-gauge pars plana vitrectomy technique by experienced vitreoretinal surgeons. Standard surgical steps included core vitrectomy, peripheral vitreous shaving with scleral indentation, drainage of subretinal fluid, retinopexy using laser or cryotherapy, and final internal tamponade according to randomized allocation.

Baseline demographic and clinical characteristics including age, gender, duration of symptoms, macular status, and presence of proliferative vitreoretinopathy were recorded preoperatively. Postoperative retinal displacement was assessed using fundus autofluorescence imaging at the 1-month follow-up visit. Retinal displacement was defined as the presence of hyperautofluorescent lines corresponding to retinal vessel printings on FAF images.

The primary outcome of the study is the incidence of postoperative retinal displacement at 1 month after surgery. Secondary analyses evaluate the relationship between retinal displacement and factors such as patient age and duration of retinal detachment prior to surgery.

Understanding the relationship between tamponade type and postoperative retinal displacement may help improve surgical planning and patient counseling regarding visual outcomes following retinal detachment repair.

Read the detailed description

Detailed Description

Background Rhegmatogenous retinal detachment (RRD) is a vision-threatening condition in which a retinal break allows fluid to accumulate in the subretinal space, leading to separation of the neurosensory retina from the retinal pigment epithelium. Surgical repair aims to achieve retinal reattachment and preserve visual function.

Pars plana vitrectomy (PPV) is a standard surgical technique for the management of RRD. The use of intraocular tamponade agents is essential to support retinal breaks postoperatively until retinopexy becomes effective. Commonly used tamponade agents include expansile gases and silicone oil, which differ in their physical properties, duration of action, and clinical indications.

Postoperative retinal displacement has been increasingly recognized following anatomically successful retinal detachment repair. This phenomenon refers to a shift in retinal position after reattachment and may contribute to visual disturbances such as metamorphopsia and diplopia despite successful surgery. Retinal displacement can be detected using fundus autofluorescence (FAF) imaging, where hyperautofluorescent lines corresponding to previous retinal vessel locations (retinal vessel printings) may be observed.

The influence of tamponade type on postoperative retinal displacement remains unclear. Additionally, there is limited data evaluating this relationship in South Asian populations.

Study Rationale Understanding whether the choice of intraocular tamponade affects the occurrence of retinal displacement may help refine surgical decision-making and improve patient counseling regarding visual outcomes following PPV for RRD.

Study Design and Setting This is a prospective, randomized, parallel-group clinical trial conducted at a tertiary care academic center. Eligible patients with primary rhegmatogenous retinal detachment undergoing pars plana vitrectomy are enrolled and randomized into two groups based on the type of intraocular tamponade used.

Randomization and Allocation Participants are randomized in a 1:1 ratio to receive either gas tamponade or silicone oil tamponade. Randomization is performed using a pre-generated random number sequence by an independent individual not involved in recruitment or surgery. Allocation concealment is ensured using sequentially numbered, opaque, sealed envelopes opened intraoperatively after retinal reattachment and prior to tamponade insertion.

Surgical Technique All procedures are performed by experienced vitreoretinal surgeons using a standardized approach. A 25-gauge three-port pars plana vitrectomy is performed, including core vitrectomy, induction of posterior vitreous detachment when required, peripheral vitreous shaving with scleral indentation, and drainage of subretinal fluid. Perfluorocarbon liquid may be used as needed.

Retinal breaks are treated with cryotherapy and/or endolaser photocoagulation. Following retinal reattachment, the assigned intraocular tamponade (expansile gas or silicone oil) is administered. Perioperative management is standardized across both groups, with the tamponade agent being the primary variable.

Outcome Assessment Postoperative evaluation includes fundus autofluorescence imaging using a standardized imaging system. Imaging is performed postoperatively, with the primary assessment based on images obtained at approximately one month, when adequate visualization is expected across both groups.

Retinal displacement is identified by the presence of hyperautofluorescent lines corresponding to previous retinal vessel positions. Images are graded using predefined criteria and categorized as demonstrating displacement, no displacement, or unassessable due to poor quality. Unassessable images are excluded from the primary analysis.

Data Collection and Analysis Baseline demographic and clinical characteristics are recorded prospectively. Statistical analysis is performed using standard software. Continuous variables are summarized using appropriate measures of central tendency and dispersion, while categorical variables are summarized as frequencies and percentages.

Comparative analysis is conducted between groups to evaluate differences in the proportion of eyes demonstrating retinal displacement. Appropriate statistical tests are applied based on data type and distribution, with a significance threshold set at p < 0.05.

Being tested
Pars plana vitrectomy
Keywords
retinal detachment, rhegmatogenous retinal detachment, fundus autofluorescence, retinal shift
Medical subject headings
Retinal Diseases, Retinal Detachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pars plana vitrectomyProcedure or surgery

    Arm 1: Gas Tamponade

    Intervention Name: Gas Tamponade Intervention Type: Procedure

    Intervention Description:

    Participants undergo pars plana vitrectomy (PPV) for rhegmatogenous retinal detachment, followed by intraocular gas tamponade using either 20% sulfur hexafluoride (SF₆) or 18% perfluoropropane (C₃F₈). The surgical steps include:

    Induction of posterior vitreous detachment (if needed)

    Core and peripheral vitrectomy with base shaving

    Drainage of subretinal fluid

    Optional use of perfluorocarbon liquid (PFCL)

    Cryotherapy or endolaser retinopexy

    Insertion of intraocular gas tamponade Standardized perioperative care is applied.

    Arm 2: Silicone Oil Tamponade

    Intervention Name: Silicone Oil Tamponade Intervention Type: Procedure

    Intervention Description:

    Participants undergo pars plana vitrectomy (PPV) for rhegmatogenous retinal detachment, followed by intraocular silicone oil tamponade (1000 centistokes polydimethylsiloxane). The surgical steps include:

    Induction of posteri

Study groups in NCT07495319
Study groupRoleWhat they receive
Pars plana vitrectomy with intraocular gas tamponade (20% SF₆ or 18% C₃F₈)ExperimentalArm Type: Experimental Intervention Name: Pars plana vitrectomy with intraocular gas tamponade (20% SF₆ or 18% C₃F₈) Intervention Type: Procedure Intervention Description: Pars plana vitrectomy with intraocular gas tamponade (20% SF₆ or 18% C₃F₈).
Receives: Procedure: Pars plana vitrectomy
Vitrectomy with Silicone Oil TamponadeExperimentalArm Type: Experimental Intervention Name: Vitrectomy with Silicone Oil Tamponade Intervention Type: Procedure Intervention Description: Pars plana vitrectomy with intraocular silicone oil tamponade (1000 centistokes).
Receives: Procedure: Pars plana vitrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Retinal Displacement

    Description: Presence of retinal displacement identified by fundus autofluorescence (FAF) imaging. Retinal displacement is defined as hyperautofluorescent lines corresponding to previous retinal vessel positions (retinal vessel printings, RVPs).

    Measured: 1 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start15 Apr 2025
  3. Primary completion31 Dec 2025
  4. Study completion31 Jan 2026

Resources

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
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, parallel-group study in which participants with primary rhegmatogenous retinal detachment undergoing pars plana vitrectomy are randomly assigned to one of two intervention arms: gas tamponade or silicone oil tamponade. Allocation is concealed using sequentially numbered, opaque, sealed envelopes. The primary outcome, postoperative retinal displacement, is assessed at 1 month using fundus autofluorescence imaging. ARM 1: Gas Tamponade ARM 2: Silicone Oil Tamponade
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07495319
Sponsor's protocol ID
2025-8810-34165
Other IDs
2025-8810-34165
Acronym
TARS
Status last verified
Mar 2026
First submitted
9 Mar 2026
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared outside the study team due to patient privacy concerns and institutional policies governing clinical data. All collected data will be used solely for the purposes of this study and related publications

Questions about this trial

What is this clinical trial studying?

A study testing Pars plana vitrectomy in people with Retinal Detachment Rhegmatogenous and Vitrectomy, run by Wardah at 1 site in Pakistan.

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 31 Mar 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 Pakistan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Postoperative Retinal Displacement (time frame: 1 month after surgery). 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 31 Mar 2026.

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