Surgical treatment of retinal detachment with and without combined cataract extraction

Parsplana vitrectomy alone versus parsplana vitrectomy combined with phacoemulsification for the treatment of rhegmatogenous retinal detachment: a randomized study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15940019

Enrollment

Registered

2021-01-15

Start date

2018-12-01

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhegmatogenous retinal detachment treated by parsplana vitrectomy (PPV) Eye Diseases Retinal detachment with retinal break

Interventions

Group A: Lens-sparing technique (PPV-only) Group B: Phacovitrectomy Postoperative follow up: 6 months The method of randomisation was “equal simple ran

Oculus, Wetzlar, Germany) for noncontact, wide-angle surgery. A 25-gauge trocar with a valved cannula will be inserted transconjunctivally in the inferotemporal, superotemporal, and superonasal quadra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 48–65 years with RRD in phakic eyes 2. The presence of up to three separate retinal tears within the superior 180° of the retinal circumference with an overall extension of retinal breaks <90° 3. Proliferative vitreoretinopathy (PVR) not exceeding the grade B according to the updated classification of 1991 4. Lens opacity not exceeding the first grade of each category of the Lens Opacities Classification System III (LOCS III) scale

Exclusion criteria

Exclusion criteria: 1. Previous surgery in the affected eye (excluding corneal refractive procedures) 2. Current use of topical hypotensive medications 3. Documented diabetic or hypertensive retinopathy 4. Age-related maculopathy 5. Optic nerve vascular pathologies

Design outcomes

Primary

Measure	Time frame
1. Anatomical success rate, defined as retinal reattachment 6 months after primary surgery without reoperation (postoperative argon laser treatment on areas considered to be at risk for new rhegmatogenous events was not considered as reoperation), measured using fundoscopy at 1, 3, and 6 months	—

Secondary

Measure	Time frame
1. Final best-corrected visual acuity (BCVA) measured using the Early Treatment Diabetic Retinopathy Study chart at 4 meters at 1, 3, and 6 months 2. Intraocular pressure (IOP) (in mmHg) measured using the Goldmann applanation tonometry at 1, 3, and 6 months 3. Central macular thickness (CMT) (in micrometers) measured using on Optical Coherence Tomography scan at 1, 3, and 6 months 4. Progression of the cataract (group A only) measured using the LOCS III scale at 1, 3, and 6 months	—

Measure

Time frame

1. Final best-corrected visual acuity (BCVA) measured using the Early Treatment Diabetic Retinopathy Study chart at 4 meters at 1, 3, and 6 months 2. Intraocular pressure (IOP) (in mmHg) measured using the Goldmann applanation tonometry at 1, 3, and 6 months 3. Central macular thickness (CMT) (in micrometers) measured using on Optical Coherence Tomography scan at 1, 3, and 6 months 4. Progression of the cataract (group A only) measured using the LOCS III scale at 1, 3, and 6 months

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026