Study for optimizing preventive treatment following cataract surgery - a randomized trial

Effect of drop-less surgery compared to topical NSAID alone and combination of steroid and NSAID on central macular thickness after cataract surgery, a randomized controlled trial - Study for optimizing anti-inflammatory prophylaxis, “SOAP”

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002666-47-DK

Enrollment

470

Registered

2017-06-30

Start date

2017-11-02

Completion date

Unknown

Last updated

2020-02-01

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

Conditions

Postoperative cystoid macular edema following cataract surgery MedDRA version: 20.0 Level: LLT Classification code 10070634 Term: Irvine-Gass syndrome System Organ Class: 100000004853

Interventions

Trade Name: Pred Forte Pharmaceutical Form: Eye drops, suspension INN or Proposed INN: Prednisolone acetate Other descriptive name: PREDNISOLONE ACETATE Concentration unit: % (W/V) percent weight/volu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Criteria for inclusion • Patients with age-related cataracts • Older than 18 years • Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months. • Capacity to consent • Scheduled to undergo cataract surgery at the ophthalmic department at Rigshospitalet-Glostrup, Denmark • The surgeon must be experienced, defined by a minimum of 1000 cataract extractions completed • Only 1 eye can be included for each participant, but there are no restrictions as to whether it is the eye that undergoes surgery first or last. If both eyes of a participant are eligible, it will be decided by randomization which eye to be included in the study • Informed consent to participation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 440

Exclusion criteria

Exclusion criteria: Criteria for exclusion • Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study • Medical history of epiretinal membrane, retinal vein occlusion, retinal detachment, uveitis, glaucoma, diabetes mellitus, exudative age-related macular degeneration (AMD) or AMD with geographical atrophy • Significant complications to surgery such as posterior capsule rupture/vitreous loss, choroidal hemorrhage, and dislocated lens material • Pregnancy • Fertile women, i.e. women who are not menopausal. • Women who breastfeed

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. We want to compare topical prophylaxis with NSAID eye drops to topical prophylaxis with a combination of NSAID and prednisolone. We also want to compare topical prophylaxis with eye drops to drop-less surgery where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of the surgical procedure. In addition, we want to investigate if topical anti-inflammatory prophylaxis should be initiated preoperatively or postoperatively. ;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is change in central macular thickness, measured by optical coherence tomography, 3 months after surgery. ;Timepoint(s) of evaluation of this end point: 3 months after surgery	—

Measure

Time frame

Main Objective: The purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. We want to compare topical prophylaxis with NSAID eye drops to topical prophylaxis with a combination of NSAID and prednisolone. We also want to compare topical prophylaxis with eye drops to drop-less surgery where the anti-inflammatory drug is administered to the subtenonal space at the conclusion of the surgical procedure. In addition, we want to investigate if topical anti-inflammatory prophylaxis should be initiated preoperatively or postoperatively. ;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is change in central macular thickness, measured by optical coherence tomography, 3 months after surgery. ;Timepoint(s) of evaluation of this end point: 3 months after surgery

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Secondary

Measure	Time frame
Secondary end point(s): • Postoperative best corrected visual acuity in logarithm to the minimal angle of resolution (logMAR) • Change in intraocular pressure (IOP) • Optical nerve damage, assessed by measuring retinal nerve fiber layer (RNFL) by peripapillary optical coherence tomography (OCT) • Flare and number of cells measured by laser flare-cell photometry • Subjective patient tolerance of prophylactic treatment measured on a 4-point analog scale, where 0 = no discomfort, 1 = mild discomfort, 2 = moderate discomfort and 3 = severe discomfort. • Patient related outcome measures obtained from questionnaire;Timepoint(s) of evaluation of this end point: All outcomes except subjective patient tolerance will be measured at baseline. CMT and RNFL will be measured again 3 weeks and 3 months postoperatively. BCVA and IOP will be measured at all visits. Subjective patient tolerance will be measured 3 days and 3 weeks postoperatively. Flare and number of cells will be measured 3 days postoperatively. Patient related outcome measures will be measured at 3 months postoperatively. Evaluation of optic nerve damage will be addressed by measuring the retinal nerve fiber layer and not by perimetry because the cataractous lens would confound the baseline results of perimetry.	—

Measure

Time frame

Secondary end point(s): • Postoperative best corrected visual acuity in logarithm to the minimal angle of resolution (logMAR) • Change in intraocular pressure (IOP) • Optical nerve damage, assessed by measuring retinal nerve fiber layer (RNFL) by peripapillary optical coherence tomography (OCT) • Flare and number of cells measured by laser flare-cell photometry • Subjective patient tolerance of prophylactic treatment measured on a 4-point analog scale, where 0 = no discomfort, 1 = mild discomfort, 2 = moderate discomfort and 3 = severe discomfort. • Patient related outcome measures obtained from questionnaire;Timepoint(s) of evaluation of this end point: All outcomes except subjective patient tolerance will be measured at baseline. CMT and RNFL will be measured again 3 weeks and 3 months postoperatively. BCVA and IOP will be measured at all visits. Subjective patient tolerance will be measured 3 days and 3 weeks postoperatively. Flare and number of cells will be measured 3 days postoperatively. Patient related outcome measures will be measured at 3 months postoperatively. Evaluation of optic nerve damage will be addressed by measuring the retinal nerve fiber layer and not by perimetry because the cataractous lens would confound the baseline results of perimetry.

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Countries

Denmark

Contacts

Public ContactDpt. of Ophthalmology, Ø37

Dpt. of Ophthalmology, Rigshospitalet-Glostrup

004538634770

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026